Intravascular blood extraction systems, devices, and methods

Abstract

An intravascular blood extraction system for venotomy via a previously inserted peripheral intravascular catheter has a protective housing and / or structure and / or cannula within the structure, the cannula forming a laminar fluid path extending from a distal fluid inlet to a lateral or proximal fluid outlet orifice directly connected to the protective housing and / or structure and / or structure, and a slider or plunger actuator is connected to the fluid outlet orifice of the cannula such that distal advancement of the slider advances the cannula within the fluid vessel.

Description

Technical Field

[0001] Claims of Priority

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

[0002] Incorporation by Reference

[0002] All publications and patent applications cited herein are hereby incorporated by reference in their entirety, to the same extent as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference.

Background Art

[0003]

[0003] Blood extraction is an element necessary for several medical procedures and / or treatments. Fluid sampling is typically performed by venipuncture using a sharp needle to obtain intravenous access.

[0004]

[0004] Peripheral venipuncture and other forms of vascular access in relatively healthy patients can be a straightforward matter, but such access is often required in patients admitted to a medical institution for several days and thus experience multiple venipunctures. Generally, blood extraction by venipuncture is the most invasive procedure for inpatients who experience an average of more than two fluid collection episodes per day. Venipuncture is common and provides high-quality fluid samples, but is associated with high patient dissatisfaction due to pain from needle insertion, sleep deprivation, infections, nerve damage, inadvertent arterial puncture, thrombosis, lack of blood vessels, and hematomas. Additionally, needle handling can increase the risk of accidental needle stick injuries to providers. Finally, in patients with difficult IV access, multiple attempts that fail can lead to significant clinical delays, decreased productivity, and dissatisfaction among patients and providers.

[0005]

[0005] A possible alternative to venipuncture is the use of a peripheral intravenous catheter (PIVC). While PIVCs are inserted into the majority of hospitalized patients, several factors reduce the success rate of this procedure. Fluids collected via a PIVC must meet many requirements for accurate laboratory analysis, including being within acceptable fluid volume and quality limits, and ensuring the sample is not hemolyzed, coagulated, contaminated, and / or diluted. Often, the initial fluid sample must be discarded to remove potential contaminants. If the fluid quality is inadequate, analytical testing cannot be performed, and re-collection is required. Re-collection also leads to significant clinical delays, reduced productivity, and patient and provider dissatisfaction. Furthermore, fluid sampling via a PIVC increases the risk of hemolysis (destruction of red blood cells), contamination of the sample from infusions and drugs in previously inserted peripheral catheters, localized torsion of the catheter due to excessive catheter movement, and extravascular catheter dislodgement. Furthermore, longer catheter dwell times increase the likelihood of occlusion and / or catheter damage, thus reducing the success rate of fluid draw-in via PIVC. Finally, failure to use sterile techniques when accessing previously inserted peripheral catheters carries a risk of fluid flow infection. [Overview of the Initiative] [Problems that the invention aims to solve]

[0006]

[0006] For these reasons, it is desirable to provide improved methods and systems for needle-free blood extraction using previously inserted peripheral catheters and structures. In particular, it is desirable to provide simplified systems and assemblies to correct, reduce, or avoid one or more of the drawbacks described herein. More preferably, components are provided that are clearly visible to the user and configured to be easily and intuitively available and operated. At least some of these objectives will be achieved by the various embodiments that follow below. [Means for solving the problem]

[0007]

[0007] This specification describes systems, devices, and methods for venotomy via a previously inserted peripheral intravascular catheter.

[0008] This disclosure generally relates to intravascular blood extraction systems, devices, and methods. In particular, in some embodiments, this disclosure relates to systems, devices, and methods for inserting a cannula into a previously inserted peripheral intravascular catheter. The cannula is used to transfer a small amount of fluid from the patient to a fluid collection container connected to an intravascular blood extraction system.

[0008]

[0009] A blood extraction system may include a system or device that can be connected to a previously inserted peripheral intravascular catheter placed in the patient's blood vessels. The system may include a cannula in a flexible and / or foldable protective sheath to maintain the sterility of the cannula during the blood extraction procedure, a housing and / or structure, a slider, and a connection mechanism to the previously inserted peripheral catheter. The cannula may be made of one or more 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 the protective housing and / or structure. The distal end portion of the housing and / or structure may consist of a mechanism that connects the blood extraction system to the previously inserted peripheral intravascular catheter or a similar connector and / or connection. The slider may connect to the housing and / or structure, and / or to the cannula, and may be disposed on the outside and inside of the housing and / or structure of the device.

[0009]

[0010] In some embodiments, the blood extraction system may allow the user to collect a fluid sample using a previously inserted peripheral intravascular catheter. The cannula of the blood extraction system advances distally within the inner diameter of the catheter, thus forming a laminar fluid pathway within the previously inserted catheter and the blood extraction device. This laminar fluid pathway enables successful fluid collection from the patient's blood vessel to a fluid collection device connected to the blood extraction system.

[0010]

[0011] In some embodiments, the laminar fluid path of a blood extraction system may consist of a distal fluid orifice located at the distal end of the cannula and a lateral fluid orifice located on the side of the intravascular blood extraction housing and / or structure. The lateral orifice may consist of a connector that facilitates the connection of a fluid collection device (such as a vacuuminer). On the other hand, the position of the lateral orifice and connector in the laminar fluid path represents a more ergonomic means for mounting the fluid collection device.

[0011]

[0012] In some embodiments, the laminar fluid path of the blood extraction system may consist of a distal inlet located at the distal end of the cannula and a proximal outlet located near the proximal end of the cannula. The proximal outlet includes an orifice that connects to, engages with, or is located within a fluid transfer chamber that is directly connected to the distal lateral orifice of the laminar fluid path. The distal inlet and proximal outlet orifices contain the laminar fluid path within the cannula. The proximal outlet orifice is distal to the distal end of the slider, as described herein. The cannula has a proximal outlet orifice to allow the fluid to exit the laminar fluid path into the fluid collection chamber, as described herein. The fluid collection chamber is sealed around the cannula using polymer seals, valves, or gaskets, as described herein. The fluid collection chamber is directly connected to the housing. The seal of the fluid collection chamber prevents leakage of the fluid or a drop in vacuum pressure during use. As described herein, seals can be positioned within the fluid transfer chamber to form a seal around the cannula. Meanwhile, the position or separation of these seals, valves, or gaskets may allow the proximal orifice of the cannula to move to a predetermined position within the fluid transfer chamber.

[0012]

[0013] The cannula may be directly connected to the slider and housed within a flexible and / or foldable protective sheath. As described herein, the flexible and / or foldable protective sheath may be connected to the distal end of the housing and / or structure and directly 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 the protective housing and / or structure. The flexible and / or foldable protective sheath may appear expanded in the first position and contracted in the second position. The flexible and / or foldable protective sheath maintains a sterile barrier around the cannula at all times.

[0013]

[0014] In some embodiments, the laminar fluid path of a blood extraction system may consist of a distal inlet at the distal end of the cannula and a lateral outlet distal to the slider. The slider lateral outlet, on the other hand, may connect to a distal lateral orifice of the protective housing and / or structure, thus forming a laminar fluid path between it and the distal inlet point of the cannula. The cannula has a proximal outlet orifice to allow fluid to exit the fluid collection chamber along the laminar fluid path, as described herein. The slider outlet orifice, having a seal, valve, or gasket connection, as described herein, can be opened when the slider is connected to a structure including a lateral orifice. The seal connected to the slider prevents fluid leakage and a drop in vacuum pressure during use. The fluid path may consist of multiple inner diameters passing through the fluid path. The structure of the lateral orifice allows the slider outlet orifice to move into position and connect to a lateral orifice of the laminar fluid path in the protective housing and / or structure.

[0014]

[0015] The cannula is directly connected to the slider and may be housed within a flexible and / or foldable protective sheath. As described herein, the flexible and / or foldable protective sheath may be connected to the distal end of the housing and / or structure and directly 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 the protective housing and / or structure. As described herein, the flexible and / or foldable protective sheath in the first position may appear expanded in the first position and contracted in the second position. The flexible and / or foldable protective sheath maintains a sterile barrier around the cannula at all times.

[0015]

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

[0016]

[0017] In some embodiments, the fluid transfer tube is directly connected to the proximal end of the slider and coupled to the lateral orifice of the blood extraction device, thus 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 may consist of a flexible tube and be coiled within a flexible and / or foldable protective sheath.

[0017]

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

[0018]

[0019] In some embodiments, the cannula is directly connected to a plunger actuator. The plunger actuator may consist of an outlet port connected to a lateral orifice of the blood extraction system via a flexible transfer tube. In this embodiment, the fluid transfer tube is directly connected to the outlet port of the plunger actuator and connects to the lateral orifice of the blood extraction device, thus 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 consists of a flexible tube and may be coiled within a flexible and / or foldable protective sheath. The flexible and / or foldable protective sheath maintains a sterile barrier around the cannula at all times.

[0019]

[0020] In some embodiments, the cannula is composed of a polymer and / or metal reinforcement structure along the length of the cannula. The reinforcement structure is oriented coaxially and / or circumferentially with respect to the cannula and may extend along the entire length of the cannula or within one or more segments thereof. The reinforcement structure may include a multilayer tube and a method for making it, where the multilayer tube comprises a first inner polymer layer and a second outer polymer layer, thereby finding the first and second polymer layer reinforcement structures.

[0020]

[0021] In some embodiments, the inner layer of the cannula may consist of one or more hydrophobic materials. One or more materials may be PTFE or the like to facilitate the transfer of fluid from the blood vessel to the fluid collection device connected to the extraction device.

[0021]

[0022] In one embodiment, an intravascular blood extraction system is provided having a cannula with a laminar fluid pathway. The cannula extends from a distal fluid inlet orifice to a lateral outlet orifice disposed within a protective handle, housing, and / or structure. The laminar fluid pathway has a distal fluid inlet orifice and a lateral fluid outlet orifice, and the laminar fluid pathway extends proximal to the lateral fluid outlet orifice of the laminar fluid pathway through the protective housing and / or structure and / or one or more cavities within the structure. The fluid outlet orifice is comprised of means for connecting a fluid collection device. There is also a slider or plunger actuator connected to the fluid outlet orifice of the cannula so that the cannula advances from the distal end of the handle, protective housing, and / or structure by distal advancement of the slide. The handle, protective housing, and / or structure has a distal end and a proximal end, and the distal mechanism connects the device to a previously inserted peripheral catheter. In some embodiments, there is a flexible and / or foldable sheath comprising means for isolating the cannula from external contamination. In other embodiments, the intravascular blood extraction device has a cannula connected 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 yet another embodiment, the cannula has a laminar fluid path with a fluid path sealer connected to the proximal end of the housing to prevent backflow through the proximal orifice.

[0022]

[0023] In this embodiment and other embodiments, the cannula is sealed and protected from contamination using a flexible and / or foldable sheath, optionally the laminar fluid path has multiple orifices and cavities within the protective housing and / or structure, optionally the laminar fluid path is made of a hydrophobic material, and optionally the laminar fluid path consists of a flexible and / or foldable transfer tube disposed within the protective housing and / or structure. In yet another embodiment, the laminar fluid path extends from the distal inlet orifice of the cannula to the lateral outlet orifice of the protective housing and / or structure.

[0023]

[0024] Furthermore, or optionally, a laminar fluid path extends from the distal inlet orifice of the cannula to the proximal outlet orifice of the protective housing and / or structure. In an additional embodiment, a slider is partially located within the protective housing and / or structure, and / or moves within the boundary of the protective housing and / or structure, allowing the cannula to move from a first position inside the protective housing and / or structure to a second position outside the handle, protective housing, and / or structure. In additional embodiments, the slider has a fluid path that directly connects to the proximal fluid outlet orifice of the cannula and extends laterally to a lateral fluid outlet orifice of the protective housing and / or structure, or the slider has a fluid path that directly connects to the proximal fluid outlet orifice of the cannula and disconnects from the lateral outlet orifice of the protective housing and / or structure, or the slider has a fluid path that extends to the fluid path outlet orifice of the slider when the fluid path outlet orifice of the slider is sealed when disconnected to prevent fluid leakage and / or pressure drop loss. In yet another embodiment, the intravascular blood extraction device has a fluid path outlet orifice of the slider that opens when connected to the lateral outlet orifice of the protective housing and / or structure using seals, valves, gaskets, or other mechanisms. In yet another alternative, the protective housing and / or structure is comprised of seals, valves, gaskets, or other mechanisms to prevent fluid leakage and / or pressure drop around the cannula, chamber, and / or other components within the protective housing and / or structure.

[0024]

[0025] In other embodiments, a method is provided for collecting blood from an existing indwelling catheter or other implanted vascular access component by connecting a blood extraction device to a previously implanted peripheral catheter that is at least partially positioned within the patient's fluid pathway. The blood extraction device includes at least a cannula with distal inlet and proximal outlet orifices that is inserted from the proximal end of the previously implanted peripheral catheter and advances distally. A slider or plunger actuator is connected to the proximal outlet orifice of the cannula to assist in inserting the cannula into and withdrawing the cannula from the previously implanted peripheral catheter. Next, a step is to connect a fluid collection device to a lateral outlet orifice of a housing, thereby transferring fluid from the patient to the fluid collection device in an ergonomic and compact form. In some embodiments, the proximal end of the cannula is connected to the distal end of a flexible tube. The flexible tube may include one or more coiled portions helically arranged around the longitudinal axis of the cannula. The distal end of the flexible tube communicates with a blood collection port on a handle or housing. The blood collection port can be advantageously positioned in one of several different locations, depending on the arrangement of the cannula and slider. For example, but not limited to, the blood collection port can be located on the side wall or proximal surface of the handle, housing, or protective structure.

[0025]

[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 at a blood collection port formed in the wall of the housing, and a connector disposed at the distal end of the housing, the connector being adapted and configured for engagement with a catheter or a peripheral vascular device. A slider is accessible from the outside of the housing and is movable with respect to the proximal end and the distal end of the housing. There is a cannula having a proximal end, a distal end, and a cannula lumen extending from the distal opening to the proximal opening, the cannula being within the housing and connected to the slider. The distal end of the cannula is movable beyond the connector by an axial movement of the slider, and 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 distal end of the cannula is outside the housing and there is an established fluid path between the distal opening of the cannula and the blood collection orifice. Further, the proximal opening of the cannula lumen is either in the side wall of the cannula or at the end of a curved proximal section of the cannula. In some embodiments, there may be a fluid path seal within the cannula lumen. The distal end of the fluid path seal is adjacent to the proximal opening of the lumen in the side wall. In some embodiments also, there is a protective sheath around the cannula that is in an expanded state when the blood extraction device is in the first position and in a contracted position when the blood extraction device is in the second position. In other aspects, when the protective sheath is in the contracted position, the sheath is either distal to or proximal to the blood collection orifice. All methods and devices described herein are contemplated in any combination and can be used to achieve the benefits described herein.

[0026]

[0027] In an additional embodiment, there is a blood extraction device having a housing having a proximal end and a distal end, and a blood collection orifice in a blood collection port formed in the wall of the housing. There is a coupling disposed at the distal end of the housing. The coupling is adapted and configured for engagement with a catheter or peripheral vascular device. A slider is accessible from the outside of the housing and is movable with respect to the proximal and distal ends of the housing. There is a cannula having a proximal end, a distal end, and a cannula lumen extending from the distal opening to the proximal opening, the cannula is located within the housing and connected to the slider. The distal end of the cannula is movable beyond the coupling by the axial movement of the slider. The blood extraction device is in a first position when the cannula is inside the housing and the proximal opening of the cannula lumen is closer to the proximal end of the housing than to the distal end of the housing, and the blood extraction device is in a second position when the distal end of the cannula is outside the housing and the distance of the proximal end of the cannula lumen from the blood collection orifice is smaller than in the first position. In some alternatives, the proximal opening of the cannula lumen is on the side wall of the cannula, while in other variations, the proximal opening of the cannula lumen is connected to a flexible tube section that communicates with the blood collection orifice. In one alternative, the flexible tube section contains multiple coils, and the spacing between adjacent coils is greater in the first position than in the second position. There may also be a protective sheath around the cannula that is expanded when the blood extraction device is in the first position and contracted when the blood extraction device is in the second position, or the sheath is proximal to the blood collection orifice when the protective sheath is in the contracted position. In one configuration, the slider is configured as a plunger actuator extending from the proximal end of the housing, and the movement of the plunger actuator causes corresponding movement of the distal and proximal openings of the cannula lumen, and also changes the distance between the proximal opening of the cannula lumen and the blood collection orifice. In one variant, the distal movement of the plunger actuator reduces the distance between adjacent coils of multiple coils within the flexible tube section.

[0027]

[0028] In another alternative, there is a blood extraction device having a housing with a proximal end and a distal end, and a blood collection orifice within a blood collection port formed in a wall at the proximal end of the housing. There is a coupler disposed at the distal end of the housing. The coupler is adapted and configured for engagement with a catheter or a peripheral vascular device. Also, there is a fixed slider and a movable slider accessible from the outside of the housing, and the movable slider is movable with respect to the proximal and distal ends of the housing. There is a cannula having a proximal end, a distal end, and a cannula lumen extending from the distal opening to the proximal opening, and the cannula is within the housing and connected to the movable slider. The distal end of the cannula is movable beyond the coupler by the axial movement of the movable slider, and when the cannula is within the housing, the blood extraction device is in a first position, and when the distal end of the cannula is outside the housing and the proximal opening of the cannula and the blood collection orifice are closer to the fixed slider than in the first position, the blood extraction device is in a second position. In one alternative, there is a protective sheath around the cannula between the fixed slider and the movable slider that is in an expanded state when the blood extraction device is in the first position and in a contracted position when the blood extraction device is in the second position. In some embodiments, the proximal opening of the cannula lumen is connected to a flexible tube section that communicates with the blood collection orifice. The flexible tube section may include a plurality of coils, and the spacing between adjacent coils is greater in the first position than in the second position, or the flexible tube section includes a plurality of coils and the spacing between adjacent coils is the same in the first position as in the second position. Also, the spacing between the fixed slider and the movable slider may be smaller in the second position than in the first position.

[0028]

[0029] Another alternative involves a blood extraction device with a housing. The housing has a connector located at the distal end of the housing, configured to engage with a catheter assembly. There is a slider communicating with the housing, configured to move between the distal and proximal ends of a handle, and a cannula including a distal end configured to extend through the distal end of the handle when the slider advances distally within the handle. Furthermore, the blood collection device is in fluid communication with the proximal end of the cannula when the distal end of the cannula is extended into the blood vessel. Another alternative is that the cannula may include a discontinuous lumen between the distal and proximal ends of the cannula, and the discontinuous lumen may be configured to transition from a discontinuous lumen to a continuous lumen when the proximal end of the cannula is aligned with a blood collection device connected to the orifice of the handle. In another variant, the cannula includes a discontinuous lumen having a linear segment distal to a flexible segment coiled within 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 the handle, the lumen configured to direct blood flow in a first direction through the linear segment and in the opposite direction through the flexible segment. In these and other embodiments, there is also an orifice extending from outside the handle into the handle and configured to connect to a blood collection device located outside the orifice. The proximal end of the cannula communicates with the orifice. There may also be an orifice extending from outside the handle into the handle and configured to connect to a blood collection device located outside the orifice, the proximal end of the cannula communicates with the orifice. In another embodiment, there may be a fluid transfer chamber configured to move blood between the proximal end of the cannula and a blood collection device. The fluid transfer chamber is located inside the handle. In some embodiments, the slider is a plunger that extends from the proximal end of the handle to the cannula.The blood collection device is a vacuuminer assembly located on the handle and configured to connect to a fluid-communicating orifice. In yet another embodiment, the cannula is configured to transition from a retracted position to an extended position in which the distal end of the cannula extends beyond the distal end of the handle as the slider advances distally within the handle. In yet another embodiment, the cannula includes a lateral opening to a lumen extending between the proximal and distal ends, and the opening of the cannula is configured to align with the blood collection device fluidly when the slider advances the cannula well beyond the distal end of the handle. There may be a fluid transfer chamber located distally within the handle, and the cannula is able to advance through the fluid chamber via one or more seals configured to seal the fluid chamber as the cannula is extended or retracted through the handle, in order to align the lateral opening of the cannula with the inside of the fluid transfer chamber. In yet another embodiment, the lumen of the cannula is configured to be continuous when the lateral opening is aligned with the interior of the fluid transfer chamber, or the lumen of the cannula is in fluid communication with the blood collection device along the length of the deployment, which includes the length of the fluid transfer chamber inside the handle.

[0029]

[0030] In yet another embodiment, a blood collection device is provided, comprising a handle having a proximal end and a distal end, with a hollow interior extending between the proximal and distal ends, and a connector located at the distal end configured to engage with a catheter assembly. The device includes a fluid transfer chamber at the distal end inside the handle, with seals located on the proximal and distal sides of the fluid transfer chamber, and a slider accessible from the outside of the handle, with a portion extending into the handle and configured to advance distally from the proximal side of the handle towards the proximal side of the fluid transfer chamber. A cannula having a lumen extending between a proximal end and a distal end, the lumen being axially aligned and extending from a slider through a fluid transfer seal along a lateral opening of the cannula between the proximal and distal ends of the cannula and exiting from the distal end of a handle, wherein the lumen is advanced by the slider beyond the proximal side of the fluid transfer chamber to fluidly communicate with the fluid transfer chamber, and is configured 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 communicating with the fluid transfer chamber.

[0030]

[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 and distal ends, a connector positioned at the distal end and configured to engage with a catheter assembly, an orifice extending through the handle and an engaging element outside the orifice configured to engage with a blood collection device. There is also a slider plunger that is accessible from the outside of the handle and extends into the handle. The slider plunger is configured to advance distally through the handle, and the cannula has a lumen extending within the handle through a linear distal portion and a flexible proximal portion spirally communicating with a segment of the slider plunger, the linear portion of the cannula is configured to be axially aligned with the handle and extend from the distal end of the handle to establish blood flow from the blood vessel when the slider is advanced distally within the handle. In some alternatives, there is a coil of the flexible portion of the cannula spirally wound around the plunger, which is configured to contract when the slider is advanced distally and the distal end of the cannula is extended beyond the handle. In one alternative, the orifice is located at the distal end of the handle, and the proximal end of the cannula is in fluid communication with the orifice. In another alternative, the coil of the flexible portion of the cannula spirally wound around the plunger is configured to lengthen when the slider is advanced distally and the distal end of the cannula is extended beyond the handle. In yet another variation, the orifice is located at the proximal end of the handle, and the proximal end of the cannula is in fluid communication with the orifice.

[0031]

[0032] Furthermore, in other alternatives, the various blood collection devices described above and herein can be advantageously used in a wide range of different ways to collect blood from a patient's blood vessels using an indwelling catheter, based on the many unique attributes and design configurations of the various embodiments. In one exemplary embodiment, there is a step of connecting the distal end of one of the blood extraction devices described above or herein to an indwelling catheter or other peripheral vascular access device communicating with the patient's blood vessel. Next, there is a step of advancing the distal end of the cannula into the patient's blood vessel beyond the housing of the blood extraction device. Here, the step of advancing the distal end of the cannula 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. Blood is collected using the blood collection orifice in the housing.

[0032]

[0033] A better understanding of the features and advantages of the methods and apparatus described herein can be obtained by referring to the following detailed description and accompanying drawings illustrating exemplary embodiments. [Brief explanation of the drawing]

[0033] [Figure 1]

[0034] This figure shows an example of an intravascular blood extraction device according to an embodiment, in which a cannula extends beyond the distal end of a protective housing and / or structure and / or structure, as described herein. The blood extraction device has a lateral outlet orifice for connection to a fluid collection device. [Figure 2]

[0035] This figure shows an example of an intravascular blood extraction device according to an embodiment, in which a cannula is retracted into a protective housing and / or structure and / or structure, as described herein. The blood extraction device has a lateral outlet orifice for connection to a fluid collection device. [Figure 3]

[0036] As described herein, this is a diagram of an intravascular blood extraction device according to an embodiment, in which an example of a laminar fluid path within the distal end of a slider is directly connected to a cannula protected by a flexible and / or foldable sheath disposed within a protective housing and / or structure. [Figure 4]

[0037] This figure shows an embodiment of an intravascular blood extraction device in which an example of a cannula extends distally beyond the distal end of the housing and / or structure, as described herein. [Figure 5]

[0038] As described herein, this is a diagram of an intravascular blood extraction device according to an embodiment, in which an example of a laminar fluid path within the distal end of a slider is directly connected to a cannula protected by a flexible and / or foldable sheath disposed within a protective housing and / or structure. [Figure 6]

[0039] This figure shows an embodiment of an intravascular blood extraction device in which an example of a cannula extends distally beyond the distal end of the housing and / or structure, as described herein. [Figure 7]

[0040] As described herein, this figure shows an example of an intravascular blood extraction device in which a laminar fluid path within the distal end of a plunger actuator is directly connected to a cannula protected by a flexible and / or foldable fluid transfer tube disposed within a protective housing and / or structure. [Figure 8]

[0041] This figure shows an embodiment of an intravascular blood extraction device in which an example of a cannula extends distally beyond the distal end of the housing and / or structure, as described herein. [Figure 9]

[0042] As described herein, this is a diagram of an intravascular blood extraction device according to an embodiment in which an example of a laminar fluid path within the distal end of a slider is directly connected to a cannula protected by a flexible and / or foldable fluid transfer tube disposed within a protective housing and / or structure. [Figure 10]

[0043] This figure shows an embodiment of an intravascular blood extraction device in which an example of a cannula extends distally beyond the distal end of the housing and / or structure, as described herein. [Figure 11]

[0044] Figure 8 shows a cross-sectional view of the intravascular blood extraction device, illustrating the additional details of the flow path through the lumen. [Modes for carrying out the invention]

[0034]

[0045] Intravascular blood extraction devices may include a cannula at least partially disposed within a housing and / or structure. The housing is also called a handle. The cannula may be configured to traverse the length of a previously inserted catheter until access to the fluid tube is achieved. Once inside the blood vessel, it may be desirable to advance it beyond the distal end of the catheter into the vessel. A cannula structure of one or more materials of a given length may be selectively manipulated (e.g., advanced or retracted) to a desired position within the blood vessel. The cannula structure can enhance the function, control, and effectiveness of the device.

[0035]

[0046] As described herein, intravascular blood extraction devices may include cannulas of one or more materials oriented coaxially or circumferentially. For example, a stiffer cannula cross-sectional shape using one or more materials. As described herein, the cannula may have an outer periphery including a soft, non-traumatic outer polymer layer, a lubricating inner layer that impairs the segments of the laminar fluid path, and a stiffer layer within the aforementioned two layers to give the cannula rigidity and column strength. As described herein, the reinforcing layer may consist of one or more materials to give the cannula the desired rigidity.

[0036]

[0047] In some embodiments, coaxial reinforcing segments within the outer and inner layers of the cannula may be arranged along the length of the cannula (e.g., stripped segments). The coaxial reinforcing segments may surround the entire circumference of the cannula (0 to 360 degrees) or be partially arranged within the outer periphery (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 embodiments, as described herein, multiple reinforcing segments may be included along the length of the cannula, such that the outer periphery of the cannula is composed of multiple reinforcing segments.

[0037]

[0048] In some embodiments, the reinforcing layer of the cannula may consist of a softer distal end. For example, a softer distal end can provide non-traumatic tip insertion into the blood vessel while maintaining the required rigidity and structure of the cannula proximal to the tip segment. On the other hand, as described herein, the softer segment may have a predetermined length of at least 0.5 mm and extend proximal along the length of the cannula.

[0038]

[0049] As described herein, an intravascular blood extraction device may consist of a cannula having a proximal end directly connected to the inlet port of a plunger actuator. The plunger actuator, as described herein, is partially located within the housing and / or structure and extends proximal to the outside of the housing and / or structure of the intravascular blood extraction device. The plunger has an inlet port at the distal end of the plunger actuator, which is connected to the proximal end of the cannula. The inlet and outlet ports of the plunger are located at the distal end of the plunger actuator, forming a laminar fluid path with the distal end of the cannula. The outlet port of the plunger actuator is connected to the lateral upper end of the intravascular blood extraction device using a flexible transfer tube. The laminar fluid path in this embodiment is created by a fluid path from the distal end of the cannula extending into the fluid path formed between the inlet and outlet ports of the plunger actuator and a flexible transfer tube directly connected to the lateral upper end of the intravascular blood extraction system. In some embodiments, a protective housing and / or structure is sealed to protect the cannula from contaminants. The housing and / or structure is sealed distally around the cannula and proximal around the plunger actuator to prevent contamination of the cannula when it is in the first position. In some embodiments, the plunger actuator can move the cannula from the first position within the protective housing and / or structure to a distal position outside the protective housing and / or structure, as described herein. The distal end portion of the protective housing and / or structure may consist of a mechanism for connecting the blood extraction system to a previously inserted peripheral intravascular catheter or similar connector and / or connection.

[0039]

[0050] The intravascular blood extraction device may consist of a cannula protected by a foldable and flexible sheath disposed within the housing and / or structural framework of the intravascular blood extraction device, as described herein. The cannula is directly connected to the distal end of a slider and is located within the flexible and / or foldable protective sheath. The slider is connected to the cannula, 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 foldable protective sheath may appear expanded in the first position and contracted in the second position. The flexible and / or foldable protective sheath maintains a sterile barrier around the cannula at all times.

[0040]

[0051] The foldable and flexible sheath has a distal end and a proximal end and is connected 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 structure inside the housing and / or structure to a distal position outside the protective sheath and / or structure. The flexible and / or foldable protective sheath may appear expanded in the first position and contracted in the second position. The flexible and / or foldable protective sheath maintains a sterile barrier around the cannula at all times.

[0041]

[0052] Figure 1 shows an example of an intravascular blood extraction device 100a in a second and open laminar fluid path position, which is extended forward and therefore the cannula 101 is partially located outside the protective housing and / or structure 102, as described herein. An example of a blood extraction device with a forward-extended cannula is shown, in which the cannula distal orifice 103, which is directly connected 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 path sealer 107 is attached to the proximal end of the protective housing and / or structure to prevent backflow through the cannula fluid path 108 until the cannula proximal orifice 109 is inside the fluid transfer chamber 110. The distal end 115 of the fluid path sealer 107 is aligned with the lateral blood collection orifice 111, as shown in Figures 1 and 2. As shown in Figure 1, with the cannula extended distally, the proximal opening of the cannula aligns with the distal end 115 of the fluid sealer. The fluid transfer chamber 110 is directly connected to the lateral upper orifice 111, thus forming a laminar fluid pathway intravascular blood extraction device. The fluid transfer chamber seals around the cannula with a seal 112a, a valve 112b, and a gasket 112c to prevent fluid leakage and a drop in vacuum pressure during use. Meanwhile, the fluid pathway formed between the distal end of the cannula and the female Luer connector of the lateral orifice may have a continuous inner diameter of the same size or multiple inner diameters of different sizes to allow fluid to flow without causing hemolysis or to assist the fluid flow during use.

[0042]

[0053] The lateral orifice 111 is a female Luer connector to which a fluid collection holder and / or syringe can be connected. As the slider moves the distal orifice of the cannula from a first position inside the protective housing and / or structure to a second position outside the protective housing and / or structure of the intravascular blood extraction device, the flexible and / or foldable protective sheath 113 folds. In this example, the fluid is extracted through the fluid pathway of the cannula and through the proximal orifice of the cannula into the fluid transfer chamber. The transfer chamber is connected to a lateral upper end device (not shown) from which the fluid is collected.

[0043]

[0054] Device 100a may include a protective housing 102 having a connector 200, the connector 200 located at the distal end of the housing 102 and connected to a catheter or other vascular access component, so that the cannula 101 can be extended through the blood vessel into the blood vessel. A slider 106 can be moved distally or proximal to adjust the deployed length of the cannula 101. In some embodiments, when the cannula 101 is deployed, the slider 106 and the distal end 105 of the slider are around the cannula 101 inside the housing 102, compressing the proximal protective sheath 113 of the fluid transfer chamber 110.

[0044]

[0055] In some embodiments, the lumens of the devices described herein may be discontinuous. As shown in Figures 1 and 2, the cannula 101 has a lumen from the distal orifice 103 to the proximal orifice 109. Thus, the lumen from the distal orifice 103 is discontinuous, and no fluid path is provided until the cannula 101 is deployed and the proximal orifice 109 is positioned within the fluid transfer chamber 109. In some embodiments, a fluid path sealer 107 may extend into the cannula lumen to prevent fluid from flowing proximal within the lumen beyond the distal end of the fluid path sealer 107. As shown in Figure 1, the fluid path sealer is positioned within the cannula 101 such that the proximal orifice is not open to the fluid transfer chamber 110 until the cannula is fully deployed over the fluid path sealer 107 when the cannula 101 is deployed.

[0045]

[0056] Seals 112a, 112b, and 112c are illustrated as cross-sectional seals positioned within the protective housing 102 and around the outside of the cannula to prevent fluid from flowing outside the cannula. One or more seals may be positioned within and around the protective housing to prevent accidental fluid movement through the device outside the cannula. Some other examples of seals include seals around the lateral upper end 111 of the protective housing 102. The lateral upper end (e.g., a connector feature) may be configured to engage with a vacuuminer assembly to transfer fluid from the cannula to a container or receptacle such as a vacuuminer.

[0046]

[0057] Figure 2 shows an example of an intravascular blood extraction device 100a in a first and closed configuration in which the cannula 101 is retracted into the protective housing and the proximal orifice 109 is not aligned with the fluid transfer chamber 110. In this position, as described herein, the cannula is initially positioned within the protective housing and / or structure 102, and the extended flexible and / or foldable protective sheath 115 is shown when the cannula is initially positioned 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 and the cannula 101 and distal orifice 108 in a stowed configuration.

[0047]

[0058] Figures 3 and 4 show an example of an intravascular blood extraction device 100b having a cannula 121, which has a distal end 122 located in a first position inside the protective housing and / or structure 123, and a slider outlet port 124. The slider outlet port 124 can be connected to a lateral orifice port 125 of the protective housing 123. The cannula 121 extends from the distal opening 122 to the slider outlet port 129, with a curved section 129 where it crosses the slider 126 and passes through the slider distal end 126a. The slider outlet port 124 can be fluidically connected to the opening 125 so that when both ports are fully engaged, the fluid can follow a laminar fluid path and flow into the lateral orifice of the laminar fluid path. As described herein, device 100b has a slider exit port 129, which is a proximal opening that is sealed or otherwise not in fluid communication with the lateral orifice 125 of the protective housing, from a distal end 122 that can be deployed into a blood vessel, and another example of a discontinuous lumen through the cannula 121. This discontinuous lumen remains out of fluid alignment or communication with the lateral orifice 125 until the slider 126 is advanced distally and the cannula is moved distally so that the slider exit port 124 is in fluid communication with the lateral orifice 125 via the connector 127.

[0048]

[0059] In some embodiments, the slider's outlet port 124 communicates with a lateral orifice 125, which may include a seal, valve, or gasket connection 127, and opens when the slider 126 connects with the lateral orifice 125 of the intravascular blood extraction device at its most distal or anterior position. The slider's outlet port 124 has a seal, valve, or gasket connection 129, as described herein, to prevent fluid leakage or a drop in vacuum pressure during use. The position or separation of these seals, valves, or gaskets allows the slider outlet port to move into a predetermined position and connect with the lateral orifice of the laminar fluid path.

[0049]

[0060] In some embodiments, the cannula is initially positioned inside the protective housing 123 via a protective sheath 130. In some embodiments, the protective sheath 130 may be foldable as the slider 126 advances distally through the housing 123. As shown in Figure 3, the device 100b is configured to be either ready for immediate use with the protective sheath extended or retracted. For example, as shown in the figure, the device is in its first and closed laminar fluid path position, with the cannula 121 initially positioned inside the protective housing 123 and / or structure, and the extended flexible and / or foldable protective sheath 130 is shown when the slider 126 is moved to its most proximal position in the intravascular blood extraction device 100b.

[0050]

[0061] Figure 4 shows the device of Figure 3, where the cannula 121 is extended through the coupling mechanism 200 beyond the distal end of the housing 123, and the slider exit port 124 is now in fluid communication with the lateral orifice 125, allowing the flow to proceed through the cannula 121 and exit the protective housing for collection, so that the distal opening 122 of the cannula 121 is ready to direct the blood flow through the cannula towards a collection device (not shown). The slider 126 is in an advanced position within the handle 123, and the distal end 126a of the slider retracts the protective sheath 130. In some embodiments, the extended length of the cannula 121 may be based on the advanced length of the slider 126 through the inside of the handle 123a.

[0051]

[0062] In some embodiments, the cannula extends forward at its second and open laminar fluid path position, partially positioned outside the protective housing and / or structure, and exhibits a retracted, flexible and / or foldable protective sheath 130 when the slider is moved to the most distal position of the intravascular blood extraction device.

[0052]

[0063] Figures 5 and 6 show an example of an intravascular blood extraction device 100c in a first position, showing an extended flexible and / or foldable protective sheath 142, when a slider 145 is moved to the most proximal position of the intravascular blood extraction device 100c, with a cannula 143 initially configured to provide a fluid path disposed inside a protective housing and / or structure 141. As described herein, the slider 145 is disposed within a handle or protective housing 141 and / or structure to move the cannula from the first position inside the protective sheath and / or structure 142 to a distal position outside the protective sheath and / or structure. The distal end portion of the housing and / or structure 200 may consist of a mechanism for connecting the blood extraction system to a previously inserted peripheral intravascular catheter or similar connector and / or connection. The slider 145 may be connected to the housing and / or structure, and / or to the cannula, and may be disposed on the outside and inside of the device housing and / or structure. In this cross-sectional view, the slider 145, like the other sliders described herein, has a portion of the slider that is external and engageable by the user, and another portion of the slider within the protective housing 141 may extend through the protective housing, configured to operate the cannula 143 between an extended configuration and a retracted configuration. In any of the embodiments described herein, the protective housing may be circular or any other shape that allows for the exemplary arrangement of the features and elements described herein and that allows for a sealable internal environment against inadvertent flow of fluid outside the cannula.

[0053]

[0064] As described herein, the device comprises a discontinuous lumen. In some embodiments, the lumen may be discontinuous with an opening or other orifice (such as 109 in Figure 1) that remains in fluid communication with the port on the housing for blood collection until the cannula is advanced and the orifice aligns with the fluid transport chamber. In other embodiments, the lumen may be discontinuous as it relates to the configuration of the cannula passing through the device. For example, as shown in Figures 5 and 6, the discontinuous cannula 143 has a linear segment and a curved segment 143 that can be coiled or spiraled around the linear portion of the cannula, reversing the flow path direction from the distal end of the cannula to the lateral orifice or port 146 of the housing. The flexible tube 144 has a distal end 144a that communicates with the proximal end of the cannula 143. As shown in Figures 5 and 6, the distal end 144a is positioned within a slider distal end 145a and can move together with the slider distal end 145a. The distal end 144a has a curve, loop, or bend that reverses the blood flow from the proximal portion of the housing distally toward the outlet 144d located in the connector 146. The flow, now directed distally, then moves through one or more coiled segments 144b within the flexible tube 144. In one embodiment, the coiled segments 144b are positioned around the longitudinal axis of the cannula and / or housing to provide a pathway to the more distal collection port 146. In embodiments of devices 100c and 100d, the coil is positioned for the distal movement of the flow, but a flexible coil can also be used to continue the distal movement of blood toward the handle or the more proximal portion of the housing, as is most commonly seen in device 100e (see Figures 9 and 10).

[0054]

[0065] In some embodiments, the fluid path forms a laminar fluid path extending between the distal end of the cannula and the lateral orifice of the intravascular blood extraction device. The laminar fluid path consists of a cannula fluid path directly connected to the distal end of the slider, a flexible transfer tube 144 connected to the distal end of the slider 145, and the lateral orifice of the intravascular blood extraction device. The flexible transfer tube 144b may be housed in a flexible and / or foldable protective sheath 142. On the other hand, the fluid path formed between the distal end of the cannula and the female Luer connector of the lateral orifice may have a continuous inner diameter of the same size or multiple inner diameters of different sizes to allow fluid to flow without causing hemolysis or to assist the fluid flow during use.

[0055]

[0066] In some embodiments, the cannula is initially positioned inside the protective housing and / or structure 141 in its first and closed laminar fluid path position, and the cannula is initially positioned within the protective housing and / or structure, showing an extended flexible and / or foldable protective sheath 142 when the slider is moved to the most proximal position of the intravascular blood extraction device.

[0056]

[0067] In some embodiments, the cannula, at its second and open laminar fluid path position, extends forward and is positioned partially outside the protective housing and / or structure 148, revealing a retracted, flexible and / or foldable protective sheath 146 when the slider is moved to the most distal position 147 of the intravascular blood extraction device. Referring to Figure 5, the device 100c is shown in a retracted configuration or a ready-to-use configuration in which the cannula 143 is retracted into the housing 141 and no flow path is established in the linear segment or coiled segment of the cannula 143. In Figure 6, the slider 145 is now advanced distally, so that the cannula 148 is deployed and the distal opening of the cannula 143 can be positioned intravascular or blood can be drawn via a catheter. The fluid can flow through the linear segment of the cannula 143, then over and through the coiled segments 144a and 144b to the distal opening 144c and outlet 144d of the coiled segments, and out through the connector 146 from the protective housing to the vacuuminer or other collection device, so the flow path can now be considered continuous.

[0057]

[0068] Figures 7 and 8 show examples of intravascular blood extraction devices 100d having a cannula 151 that exits from a handle or a lateral orifice 157 of a housing 154, after the proximal portion 152 of a linear segment transitions to a coiled segment 158. In some embodiments, the cannula 151 may be directly connected to the inlet port of a plunger actuator shaft 153. The plunger actuator 162 may extend from its proximal portion through a housing 154 having the actuator shaft 153. The housing shaft has a movable length 153a, which is the distance traveled for the plunger actuator to move distally before it hard stops against the outer wall of the housing or handle. The plunger distance 153a corresponds to the cannula travel distance 153b when the device 100d is in a blood collection configuration (see Figure 8). In this figure of the handle, housing, and / or structure, several sealed or protective enclosures for the cannula are visible. The plunger has an inlet port 155 at the distal end of a plunger actuator connected to the proximal end of the cannula 152. In Figure 7, the plunger actuator 162 is retracted proximal, and the cannula 151 is in a housing configuration within the housing 154. The linear segment of the cannula 151 is entirely within the housing 154, while the coiled or spiral segment extends throughout the inside of the handle. The proximal end of the cannula is connected to a lateral orifice or port 157 of the housing, ready to be connected to a fluid container during sampling.

[0058]

[0069] In some embodiments, the plunger 153 can extend into the housing 154 through a proximal seal 160 to seal the inside of the housing 154. The outlet port 156 of the plunger (e.g., the proximal end of the cannula) actuator is connected to the lateral upper end 157 of the intravascular blood extraction device using a flexible transfer tube 158 (e.g., a coiled segment of the cannula 151). The transfer tube 158 is shown in an extended configuration when the plunger is in its most proximal position. The laminar fluid path in this embodiment is created by a fluid path from the distal end of the cannula 151 extending into a fluid path formed between the inlet and outlet ports of the plunger actuator, and a flexible transfer tube directly connected to the lateral upper end of the intravascular blood extraction system. On the other hand, the fluid path formed between the distal end of the cannula and the female Luer at the lateral upper end may have a continuous inner diameter of the same size or multiple inner diameters of different sizes to allow fluid to flow without causing hemolysis or to assist the fluid flow in use.

[0059]

[0070] Figure 8 shows the device from Figure 7 in an expanded configuration, this time with the cannula 151 extending beyond the distal end of the housing 154, where length 153b corresponds to the advance of the plunger 162 in the housing 154. The coiled or flexible segment 158 ​​of the cannula is shown as a more contracted coil, still allowing flow from the distal opening of the cannula to the port 157 of the housing, which communicates with the coiled segment 158 ​​of the lumen.

[0060]

[0071] In some embodiments, the housing and / or structure is sealed distally around the cannula (159) and proximally around the plunger actuator (160) to prevent contamination of the cannula when it is in the first position.

[0061]

[0072] In some embodiments, the plunger actuator 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, as described herein. The distal end portion of the protective housing and / or structure may consist of a mechanism for connecting the blood extraction system to a previously inserted peripheral intravascular catheter or similar connector and / or connection.

[0062]

[0073] In some embodiments, the cannula, in its second forward position, extends forward and is positioned partially outside the protective housing and / or structure 154, and when the plunger 162 is moved to the most distal position of the intravascular blood extraction device, it exhibits a retracted, flexible moving tube 158.

[0063]

[0074] Figures 9 and 10 show yet another example of an intravascular blood extraction device 100e, which again has a cannula 177 having a linear segment or region distally and a coiled or spiral region 181 proximal to it. The movable slider 173b can be used in combination with the fixed slider support 173a when the movable slider wall 173c is advanced distally to advance the cannula 177 away from the handle or housing 176. The cannula 177 is connected to the movable slider wall 173c and unfolds as the movable slider 173b advances distally toward the fixed slider support 173a. The flexible movable tube or coiled segment 181 of the cannula can expand or contract in response to the deployment and retraction of the cannula. The distal end 181a of the coiled segment communicates with the proximal opening of the cannula lumen. Flow within the movable tube 181 passes through the coiled segment 181b to the proximal end 181c. The proximal end 181c of the coiled segment communicates with the outlet structures 182, 182a, and 182b, as is most commonly seen in the diagram in Figure 10.

[0064]

[0075] The distal end portion of the handle, housing, and / or structure 176 has a port or connector 178 configured to connect the blood extraction system 100e to a previously inserted peripheral intravascular catheter or similar connector and / or connection. The slider 173b is connected to the housing and / or structure and the cannula, is movable relative to them, and may be disposed on the outside and inside of the protective housing and / or structure of the device.

[0065]

[0076] In some embodiments, a flexible and / or foldable sheath 179 is directly connected to the distal end of the protective housing and / or structure 176 (see connection adjacent to the fixed slider 173a) and the movable slider 173b to prevent contamination of the cannula 177 before it enters a previously inserted peripheral catheter. The cannula, flexible or foldable sheath, and movable slider 173b may be supported by rails, walls, or other suitable support structures such as structure 172. When the cannula 177 is in a first position within the protective housing and / or structure, the flexible and / or foldable sheath 179 is extended (see Figure 9). In Figure 10, when the cannula 177 is moved to a second position outside the protective sheath and / or structure, the flexible and / or foldable sheath 179 is retracted.

[0066]

[0077] In some embodiments, as shown in the movement between Figures 9 and 10, a flexible transfer tube (e.g., a coiled or spiral segment of the cannula) 181 can transition within the housing 176 together with a linear cannula segment and a transfer slider 173b. Optionally, the coiled segment 181 can also be configured to contract to a shorter axial distance, as shown in Figures 6 and 8. In some embodiments, the linear cannula segment 175 may extend from a distal opening 177a to the coiled segment 181 and transition through a slider 173b near region 175. The spiral or flexible segment 181 of the cannula can then be connected to an orifice or connector 182, which is now located at the proximal end of the housing 176, with the opening 182a fluidizing with the cannula to allow blood flow through the cannula 177 when deployed into a blood vessel or catheter assembly.

[0067]

[0078] The embodiment shown in Figure 10 illustrates that a laminar fluid path is formed between the distal end 177a of the cannula and the proximal end of the intravascular blood extraction device via an opening 182a. The flexible cover 179 is retracted by the 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 embodiments, the proximal end of the intravascular blood extraction system may consist of a connector as a female Luer 182 or a similar structure for connecting a fluid collection device or syringe. In some embodiments, the connector 182 may have a distal opening 182b extending into the proximal end of the transfer tube 181. In some embodiments, the flexible transfer tube 181 is retractable and / or foldable, allowing the slider to move from a first position to a second position within the protective housing and / or structure 176. On the other hand, the fluid path formed between the distal end and the female Luer connector at the proximal end of the cannula may have a continuous inner diameter of the same size, or multiple inner diameters of different sizes, to allow fluid to flow without causing hemolysis, or to assist the fluid flow during use.

[0068]

[0079] It should be understood that all combinations of the above concepts and the additional concepts described in more detail below (unless such concepts are mutually contradictory) are considered to be part of the inventive subject matter disclosed herein and may be used to achieve the benefits described herein.

[0069]

[0080] Figure 11 shows a blood extraction device as described herein, with arrows indicating examples of flow paths within it. This embodiment shows a device from Figure 8 having a cannula 151 deployed so as to be intravascular and a plunger 162 in an advanced position within a housing 150. As indicated by arrow 250, the flow can proceed through the linear portion of the cannula 151 and then through the coiled or spiral section of the flexible cannula tube 158 to a port or orifice 157 for transfer to a collection device such as a vacuuminer. Arrow 255 indicates a reversal or change in the direction of flow from the linear portion, as the blood may first move proximal within the housing 150 and then move in the opposite or distal direction to the spiral segment of the cannula 151 toward the connector 157. A flow can be established when the lumen is continuous such that the flow moves in a first direction and then in a second direction. In some embodiments, a flow through a discontinuous lumen may move in the opposite manner, as shown in Figure 11. In some embodiments, as shown in Figure 1, the lumen may be discontinuous until it aligns with the fluid transfer chamber. In some embodiments, the discontinuous lumen may move through a first linear segment of the cannula, which is discontinuous as it transitions to a flexible spiral or coiled segment of the cannula into a port or orifice of the housing.

[0070]

[0081] In this specification, when a feature or element is referred to as being "on" another feature or element, it may be directly on the other feature or element, or there may be intervening features and / or elements. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements. Also, when a feature or element is referred to as "connecting," "attaching," or "linking" to another feature or element, it will be understood that it may be directly connected to, attached to, or linked to the other feature or element, or there may be intervening features or elements. In contrast, when a feature or element is referred to as "directly connecting," "directly attaching," or "directly linking" to another feature or element, there are no intervening features or elements. Features and elements described or shown in relation to one embodiment may be applicable to other embodiments. Also, when a reference to a structure or feature positioned "adjacent" to another feature, it will be understood by those skilled in the art that there may be parts that overlap with or lie beneath the adjacent feature.

[0071]

[0082] The terms used herein are intended to describe only specific embodiments and are not intended to limit the invention. For example, as used herein, the singular forms “a,” “an,” and “the” are intended to include the plural form unless the context clearly indicates otherwise. Furthermore, the terms “comprise” and / or “comprising,” as used herein, specify the presence of a stated feature, step, operation, element, and / or component, but it will be understood that this does not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the terms “and / or” include any or all combinations of one or more of the related listed items and may be abbreviated as “ / ”.

[0072]

[0083] To describe the relationship between one element or feature shown in a figure and another, spatial relative terms such as “directly below,” “below,” “below,” “above,” and “above” may be used herein to facilitate explanation. It will be understood that spatial relative terms are intended to encompass different orientations of the device in use or operation, in addition to the orientation shown in the figure. For example, if the device in the figure is inverted, an element described as “directly below” or “below” another element or feature would be oriented “above” the other element or feature. Thus, the exemplary term “directly below” can encompass both “above” and “below” orientations. The device may be oriented by other means (e.g., rotated 90 degrees or in other orientations), and the spatial relative descriptors used herein will be interpreted accordingly. Similarly, terms such as “upward,” “downward,” “vertical,” and “horizontal” are used herein for illustrative purposes only, unless otherwise noted.

[0073]

[0084] In this specification, the terms “first” and “second” may be used to describe various features / elements (including steps), but these features / elements should not be limited by these terms unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another. Thus, without departing from the teachings of the invention, the first feature / element described below may be referred to as the second feature / element, and similarly, the second feature / element described below may be referred to as the first feature / element.

[0074]

[0085] Throughout this specification and the subsequent claims, unless the context requires otherwise, the word “comprise,” and variations such as “comprises” and “comprising,” mean that various components can be used together in methods and articles (e.g., compositions, or apparatus including devices and methods). For example, the term “comprising” will be understood to mean including any specified element or step, but not excluding other elements or steps.

[0075]

[0086] Generally, all apparatuses and methods described herein should be understood to be comprehensive, however all or a subset of components and / or steps are alternatively exclusive and can be described as "composed of" or "essentially composed of" various components, steps, sub-components, or sub-steps.

[0076]

[0087] Where used herein and in the claims (including where used in examples, and unless otherwise expressly specified), all numbers may be read as if preceded by the word “about” or “approximately,” even if the term does not explicitly appear. The phrase “about” or “approximately” may be used when describing magnitude and / or location to indicate that the described value and / or location is within a reasonable predictable range of the value and / or location. For example, a number may have values ​​that are + / -0.1% of a specified value (or range of values), + / -1% of a specified value (or range of values), + / -2% of a specified value (or range of values), + / -5% of a specified value (or range of values), + / -10% of a specified value (or range of values), and so on. Also, any number given herein should be understood to include about or approximately that value unless the context indicates otherwise. For example, if the value “10” is disclosed, “about 10” is also disclosed. Any numerical range referred to herein is intended to include all subranges contained therein. Furthermore, when a value is disclosed, it is understood that the possible ranges of "less than or equal to" that value, "greater than or equal to" that value, and between values ​​are also disclosed in a manner that can be appropriately understood by those skilled in the art. For example, if a value "X" is disclosed, then "less than or equal to X" and "greater than or equal to X" (for example, X is a number) are also disclosed. Also, throughout the application, it is understood that data is provided in several different forms, and this data represents endpoints and starting points and is distributed across any combination of data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it is understood that not only the range between 10 and 15 is disclosed, but also the ranges of "greater than or equal to" 10 and 15, "greater than or equal to" 10 and 15, "less than or equal to" 10 and 15, and "equal to" 10 and 15. It is also understood that each unit between two specific units is disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0077]

[0088] While various exemplary embodiments have been described above, any of several modifications can be made to these embodiments without departing from the scope of the invention as defined in the claims. For example, the order in which the various method steps described are performed may often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps may be omitted entirely. Optional features of the various device and system embodiments may be included in some embodiments and not in others. Therefore, the above description is provided primarily for illustrative purposes and should not be construed as limiting the scope of the invention as defined in the claims.

[0078]

[0089] The examples and illustrations contained herein illustrate, not limit, specific embodiments that can put the subject matter into practice. As stated above, other embodiments can be utilized and derived therefrom, so as to allow for structural and logical substitutions and modifications without departing from the scope of this disclosure. Such embodiments of the subject matter of the invention may be referred to herein individually or collectively, merely for convenience and without the intention of arbitrarily limiting the scope of this application to a single invention or inventive concept where multiple inventions or inventive concepts are actually disclosed. Thus, although specific embodiments are illustrated and described herein, any arrangement calculated to achieve the same objective can be used in place of the specific embodiments shown. This disclosure is intended to cover any and all adapted or modified forms of various embodiments. Combinations of the embodiments described herein, and other embodiments not specifically described herein, will be apparent to those skilled in the art by considering the above description.

Claims

1. A blood extraction device, A housing having a proximal end and a distal end, A blood collection orifice in the blood collection port formed in the wall of the housing, A connector disposed at the distal end of the housing, which is adapted and configured for engagement with a catheter or peripheral vascular device, A slider accessible from the outside of the housing and movable relative to the proximal end and distal end of the housing, A cannula having a proximal end, a distal end, and a cannula lumen extending from the distal opening to the proximal opening, the cannula being located within the housing and connected to the slider, Equipped with, A blood extraction device wherein the distal end of the cannula is movable beyond the connector by the axial movement of the slider, the blood extraction device is in a first position when the cannula is inside 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 distal end of the cannula is outside the housing and there is an established fluid path between the distal opening of the cannula and the blood collection orifice.

2. The device according to claim 1, wherein the proximal opening of the cannula lumen is located on 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 according to claim 2, further comprising a fluid path sealer within the cannula lumen, wherein the distal end of the fluid path sealer is adjacent to the proximal opening of the lumen located on the side wall.

5. The device according to claims 1 to 3, further comprising a protective sheath around the cannula, which is in an expanded state when the blood extraction device is in the first position and in a retracted 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 retracted position, the sheath is distal to or proximal to the blood collection orifice.

7. A blood extraction device, A housing having a proximal end and a distal end, A blood collection orifice in the blood collection port formed in the wall of the housing, A connector disposed at the distal end of the housing, which is adapted and configured for engagement with a catheter or peripheral vascular device, A slider accessible from the outside of the housing and movable relative to the proximal end and distal end of the housing, A cannula having a proximal end, a distal end, and a cannula lumen extending from the distal opening to the proximal opening, the cannula being located within the housing and connected to the slider, Equipped with, A blood extraction device wherein the distal end of the cannula is movable beyond the connector by the axial movement of the slider, the blood extraction device is in a first position when the cannula is inside the housing and the proximal opening of the cannula lumen 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 distal end of the cannula is outside the housing and the distance of the proximal end of the cannula lumen from the blood collection orifice is smaller than in the first position.

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

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

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

11. The device according to claims 7 to 10, further comprising a protective sheath around the cannula, which is in an expanded state when the blood extraction device is in the first position and in a retracted 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 retracted position, the sheath is located proximal to the blood collection orifice.

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

14. The device according to claim 13, wherein the distal movement of the plunger actuator reduces the spacing between adjacent coils of the plurality of coils in the flexible tube section.

15. A blood extraction device, A housing having a proximal end and a distal end, A blood collection orifice in a blood collection port formed in the wall at the proximal end of the housing, A connector disposed at the distal end of the housing, which is adapted and configured for engagement with a catheter or peripheral vascular device, A fixed slider and a movable slider accessible from the outside of the housing, wherein the movable slider is movable with respect to the proximal distal end of the housing, A cannula having a proximal end, a distal end, and a cannula lumen extending from the distal opening to the proximal opening, the cannula being located within the housing and connected to the movable slider, Equipped with, A blood extraction device wherein the distal end of the cannula is movable beyond the connector by the axial movement of the movable slider, the blood extraction device is in a first position when the cannula is inside the housing, and the blood extraction device is in a second position when the distal end of the cannula is outside the housing and the proximal opening of the cannula and the blood collection orifice are closer to the fixed slider than when the device is in the first position.

16. The device according to claim 15, further comprising a protective sheath around the cannula between the fixed slider and the movable slider, which is in an expanded state when the blood extraction device is in the first position and in a retracted 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 connected to a flexible tubular section that communicates with the blood collection orifice.

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

19. The device according to claim 17, wherein the flexible tube section includes a plurality of coils, and the spacing between adjacent coils is the same at the first position as at 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 housing having a connector disposed at the distal end of the housing, configured to engage with a catheter assembly, A slider communicating with the housing, configured to move between the distal and proximal ends of the handle, A cannula including a distal end configured to extend through the distal end of the handle when the slider advances distally within the handle, When the distal end of the cannula is extended into the blood vessel, a blood collection device is in fluid communication with the proximal end of the cannula, A blood extraction device equipped with the following features.

22. The blood extraction device according to claim 21, wherein the cannula includes a discontinuous lumen between the distal end and the proximal end of the cannula, and the discontinuous lumen can be configured to transition from a discontinuous lumen to a continuous lumen when the proximal end of the cannula is aligned with the blood collection device connected to the orifice of the handle.

23. The blood extraction device according to claim 21, wherein the cannula includes a discontinuous lumen having a linear segment distal to a flexible segment coiled inside the handle.

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

25. The blood extraction device according to claim 21, further comprising an orifice extending from the outside of the handle into the inside of the handle, wherein the orifice is configured to be connected to the blood collection device located outside the orifice, and the proximal end of the cannula is in communication with the orifice.

26. The blood extraction device according to claim 24, further comprising an orifice extending from the outside of the handle into the inside of the handle, which is configured to be connected to the blood collection device located outside the orifice, wherein the proximal end of the cannula is in communication with the orifice.

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

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

29. The blood collection device is a vacuuminer assembly positioned on the handle and configured to be connected to a fluid-communicating orifice, according to claim 21, the blood extraction device.

30. The blood extraction device according to any one of claims 21 to 29, wherein the cannula is configured to transition from a storage position to an extended position in which the distal end of the cannula extends beyond the distal end of the handle as the slider advances distally within the handle.

31. The blood collection device according to claim 21, wherein the cannula includes a lateral opening to a lumen extending between a proximal end and a distal end, and the opening of the cannula is configured to be in fluid communication with the blood collection device when the slider advances the cannula well beyond the distal end of the handle.

32. The blood extraction device according to claim 31, further comprising a fluid transfer chamber located distal to the inside of the handle, wherein the cannula is able to advance through the fluid chamber via one or more seals configured to seal the fluid chamber as the cannula is extended through the handle or retracted, so as to align the lateral opening of the cannula with the inside of the fluid transfer chamber.

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

34. The blood collection device according to claim 32, wherein the lumen of the cannula is in fluid communication with the blood collection device along the length of its deployment, which includes the length of the fluid transfer chamber inside the handle.

35. A handle having a proximal end and a distal end, with a hollow interior extending between the proximal and distal ends, A connector located at the distal end, configured to engage with the catheter assembly, A fluid transfer chamber located at the distal end inside the handle, wherein seals are disposed on the proximal and distal sides of the fluid transfer chamber, A slider that can be accessed from the outside of the handle, a portion of which extends into the interior of the handle, and is configured to advance distally from the proximal side of the handle toward the proximal side of the fluid transfer chamber, A cannula having a lumen extending between a proximal end and a distal end, the lumen being axially aligned and extending from the slider through the fluid transfer seal and exiting from the distal end of the handle, The lateral opening of the cannula between the proximal end and the distal end of the cannula, Equipped with, A blood collection device wherein the lumen is advanced by the slider beyond the proximal side of the fluid transfer chamber to fluidly communicate with the fluid transfer chamber, and is configured to provide a continuous lumen from the distal end of the cannula through the lateral opening into the fluid transfer chamber and into the blood collection device communicating with the fluid transfer chamber.

36. A handle having a proximal end and a distal end, with a hollow interior extending between the proximal and distal ends, A connector located at the distal end, configured to engage with the catheter assembly, An orifice extending through the handle, wherein the external engaging element of the orifice is configured to engage with a blood collection device, A slider plunger that is accessible from the outside of the handle and extends into the interior of the handle, and is configured to advance distally through the handle, A cannula having a lumen extending within the handle through a linear distal portion and a flexible proximal portion spirally communicating with the segments of the slider plunger, wherein the linear portion of the cannula is axially aligned with the handle and extends from the distal end of the handle to establish blood flow from the blood vessel when the slider is advanced distally within the handle. A blood extraction device equipped with the following features.

37. The blood extraction device according to claim 36, wherein the coil of the flexible portion of the cannula, which is spirally wound around the plunger, is configured to contract when the slider is advanced distally and the distal end of the cannula is extended beyond the handle.

38. The blood collection device according to claim 37, wherein the orifice is located 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 according to claim 36, wherein the coil of the flexible portion of the cannula, which is spirally wound around the plunger, is configured to become longer when the slider is advanced distally and the distal end of the cannula is extended beyond the handle.

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

41. A method for collecting blood from a patient's blood vessels using an indwelling catheter, The steps of connecting the distal end of the blood extraction device according to any one of claims 1 to 40 to the indwelling catheter, A step of advancing the distal end of a cannula into the patient's blood vessel beyond the housing of the blood extraction device, thereby establishing fluid communication between the patient's blood vessel and the blood collection orifice within the housing of the blood extraction device via the proximal cannula lumen opening; Methods that include...

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