Infusion and blood collection devices and methods

Abstract

An apparatus (300) for uninterruptedly administering fluid (314) to an animal body during blood collection is disclosed. Embodiments include an intravenous device (300) defining a first fluid passageway (354) configured to selectively convey IV fluid (314) to the animal body and withdraw bodily fluid (318) from the body, and a connection member (364) configured to connect a catheter (320) to the first fluid passageway and define a concave distal end (705). A second fluid passageway (358) continuously provides IV fluid (314) to a lumen (360) coaxially located within the catheter (320). The shape of the concave surface (706) is set to produce a fluid flow pattern that rapidly and completely removes residual bodily fluid remaining at the concave distal end (705). Embodiments include a concave surface (706) defining an asymmetric funnel shape with its apex centered about the first fluid passageway (354).

Description

[0001] Cross-reference to related applications

[0002] This international PCT application claims priority to U.S. Provisional Patent Application No. 62 / 940,596, filed November 26, 2019, entitled “Apparatus and Method for Infusion and Blood Collection,” the entire contents of which are incorporated herein by reference. Technical Field

[0003] This invention relates to an infusion and blood collection apparatus and method. In particular, this invention relates to an infusion and blood collection apparatus that allows for clean blood collection via a pre-installed vascular catheter for administering intravenous fluid. The invention also relates to a method for drawing blood from a patient using the infusion and blood collection apparatus via a pre-installed vascular catheter. Background Technology

[0004] Albisser's U.S. Patent No. 3,610,226 discloses a dual-lumen cannulation device for withdrawing blood over an extended period of time. The device includes an inner lumen for withdrawing blood and an outer lumen for introducing an anticoagulant diluent. The relative positions of the openings of the inner and outer lumen allow the diluent to mix with the withdrawn blood.

[0005] Mahurkar's U.S. Patent No. 5,374,245 discloses a squeeze-reinforced multi-lumen catheter for use in medical applications in which fluid must flow into and out of a patient simultaneously. Blood is drawn from the patient through one passage for a medical procedure (e.g., dialysis) and returned to the patient through another passage spaced apart from the first passage.

[0006] Humphrey's U.S. Patent No. 5,607,401 discloses reinforced polymeric hypodermic needles and lancets. These polymeric needles and lancets are reinforced by a reinforcing device including a sliding shield or foam insert, thus enabling them to pierce the skin. Without this reinforcing device, polymeric hypodermic lancets would not be able to pierce the skin.

[0007] U.S. Patent No. 5,637,399 to Yoshikawa et al. discloses an extruded synthetic resin needle reinforced with combustible fibers. This needle provides a single pathway for administering or withdrawing fluid from a patient.

[0008] The prior art described above does not provide a catheter assembly that can be inserted into a patient for an extended period of time to simultaneously administer intravenous fluid and periodically withdraw blood without mixing the intravenous fluid with the withdrawn blood.

[0009] U.S. Patent No. 6,758,835 to Close et al. discloses a microinjection-molded disposable needle assembly having more than one channel formed therein to allow simultaneous extraction and administration of fluid through individual channels. The microinjection-molded disposable assembly includes one or more sensors disposed therein for measuring and monitoring one or more desired bodily or environmental conditions. The patent also discloses a method for forming the disposable needle from an elastomeric material using microinjection molding.

[0010] The present invention herein is in part an extension of the apparatus and method disclosed in U.S. Patent No. 6,758,835 to Close et al. Therefore, the disclosure of U.S. Patent No. 6,758,835 is incorporated herein by reference in its entirety.

[0011] The devices described in the prior art above mainly focus on the catheter portion of the needle assembly, which can be inserted into the patient for an extended period of time to simultaneously administer intravenous fluid and aspirate blood without mixing the intravenous fluid with the aspirated blood.

[0012] Unlike the prior art described above, this invention does not primarily focus on the catheter portion of the needle assembly. Instead, this invention provides a device that can be inserted between a previously installed standard intravenous (IV) catheter (e.g., a peripheral venous catheter) and a standard IV infusion line, allowing for clean blood collection without interrupting IV therapy administration to the patient. For example, for any blood collection obtained from a peripheral catheter, the IV infusion pump is typically stopped for 30 seconds or longer, and the connection between the IV catheter and the infusion line is disconnected to allow the blood sample to be taken through the IV catheter and to prevent mixing of the infusion with the blood collection, which could lead to erroneous results. If the IV infusion pump is not stopped and the infusion administration is stopped using a downstream valve (e.g., a 2-way, 3-way, or 4-way stop valve), this triggers a pump alarm, requiring staff attention as the line is considered blocked. This fluid infusion constraint alarm on the IV infusion pump is typically triggered when the infused fluid increases to more than 10 psi. The device provides a means to avoid interrupting IV therapy, preventing the IV infusion pump from being shut down or the infusion restraint alarm from being triggered. Furthermore, the device aims to reduce the complexity of the flow delivery components of commonly used infusion and blood collection devices. Therefore, while some prior art techniques actively sense and control pressure to ensure clean blood collection, in this invention, pressure can be passively, or alternatively or additionally, actively controlled.

[0013] When a patient is admitted to a hospital, emergency room, or other medical facility, in the vast majority of cases, the patient will receive one or another type of IV catheter. In some cases, the IV catheter is placed in place immediately after admission to administer the required treatment to the patient. In other cases, the IV catheter is placed in place solely for risk management reasons so that the catheter is ready in case healthcare personnel need to administer medication or fluids to the patient quickly. The cannula portion of the IV catheter is inserted into a blood vessel typically in the forearm, hand, or another location on the patient's body (i.e., the body of any animal, such as humans, canines, felines, horses, etc.), and the connection portion of the IV catheter used to allow IV infusion is typically secured to the outside of the patient's body using a variety of available tapes, strips, bandages, or other devices.

[0014] The typical hospital stay for patients averages approximately three days, during which two or more sets of laboratory tests are reportedly performed daily. This means that medical technicians will have to perform blood collections from patients at least twice a day, which are then sent to the laboratory for testing and / or analysis. Typically, if the patient already has a catheter attached to the appropriate location on one arm (through which medications or fluids are being administered), the medical technician will have to use the patient's other arm or another part of the patient's body to perform the blood collection. This means that during the average three-day hospital stay, patients have at least six opportunities for repeated needle pricks, which translates to at least six opportunities to initiate potential infection, hematoma, missed stick, and skin irritation due to tape and other devices. Furthermore, especially in cases involving pediatric patients, hemophiliac patients, HIV patients, patients with dementia and / or similar conditions, and / or other emotionally agitated patients who may experience needle prick fear, or those with other increased risks associated with additional needle insertion, patients may experience at least six traumatic events during their hospital stay, making the blood collection process difficult or otherwise risky.

[0015] Furthermore, in some cases, medical technicians may use catheters already implanted in a patient to draw blood for testing. In those cases, the technician must typically temporarily interrupt the administration of medications or fluids and perform a series of lengthy, cumbersome flushing steps to prevent accidental contamination of the blood sample by residual IV solution, medication, or fluid, and to ensure the blood sample is clean. Without such flushing steps, the blood sample may be diluted, for example, by residual IV solution, leading to erroneous test results. Similarly, contamination of the blood sample by residual IV solution containing sodium and / or potassium compounds, for example, will result in false test data showing higher concentrations of these compounds. Summary of the Invention

[0016] As will become apparent in the following disclosure, the apparatus and method of the present invention described herein are believed to offer advantages in alleviating and resolving all the aforementioned problems and controversies surrounding blood collection. The apparatus of this invention utilizes an IV catheter port already implanted in the patient and provides a simple procedure for performing clean blood collection without interrupting IV therapy administration after initial catheter insertion. The apparatus optionally includes passive control of the blood collection volume flow rate to prevent contamination of the collected blood by the IV therapy fluid simultaneously infused through the catheter. The apparatus of this invention is simply installed by inserting it into an IV catheter line already implanted in the patient and makes the procedural steps of blood sample collection virtually automated. Furthermore, the apparatus herein features the use of standard blood collection containers (such as those trademarked by Becton, Dickinson and Company, Franklin Lake, New Jersey). Or (a trademark of Greiner Bio One, Monroe, North Carolina) The vacuum inside the tube is an advantage as a driving mechanism for drawing blood samples from patients.

[0017] In an illustrative embodiment of the device (where the distal / proximal side is a reference device rather than the patient's body), a medical tube (e.g., a microlumen) is coaxially inserted through another medical tube (e.g., a catheter) already inserted into the patient and extends distally outward from the distal end of that tube. The microlumen and catheter are in fluid communication with a shunt valve and a valve housing. IV therapeutic fluid is supplied from the infusion line to the valve housing, and the valve housing provides selective operation in infusion / non-collection and infusion / collection modes. In infusion / non-collection mode, IV therapeutic fluid is supplied to both the microlumen and the catheter. In infusion / collection mode, a blood collection component, such as a vacuum collection tube holder, coupled to the collection body receives blood from the catheter, while the microlumen simultaneously continues to supply IV therapeutic fluid to the patient.

[0018] The extension length and blood collection flow rate are of significant importance to the present invention in order to prevent the aspirated blood from mixing with the IV fluid and thereby preventing contamination of the aspirated blood with the IV fluid in infusion / collection mode. For example, the pressure difference between the vacuum blood collection tube and the typical patient venous pressure is approximately two orders of magnitude. For example, the tube vacuum can be at most about 700 mmHg, and the venous pressure can be about 7 mmHg. Therefore, mixing of the collected blood with the IV fluid at the collection point in the vein is prevented by a combination of: 1) the device limiting the flow rate of blood collected from the vein and into the catheter, and 2) the distal end of the microtubule for simultaneously infusing the infusion into the vein being located sufficiently far from the distal end of the IV catheter in the vein at which blood is aspirated from the vein.

[0019] While the illustrative embodiments of the present invention relate to a vascular catheter (i.e., an IV catheter), it should be understood that, as contemplated herein, the invention may also be applied to other catheters known in the art, such as peripherally inserted cardiac catheters, central catheters, etc.

[0020] The object of the present invention is to provide an infusion and blood collection device that allows for clean blood collection from a patient via a previously installed catheter (such as a peripheral venous catheter, also known as a vascular catheter) after initial installation without interrupting the administration of intravenous therapy.

[0021] Another object of the present invention is to provide an infusion and blood collection device that allows clean blood collection from a patient via a previously installed catheter without relying on repeated needle insertions into the patient at a location on the patient's body away from the installed catheter.

[0022] Another object of the present invention is to provide an infusion and blood collection device that allows for clean blood collection from a patient via a previously installed catheter without exposing the patient to a higher risk of infection due to repeated and multiple needle pricks.

[0023] Another object of the present invention is to provide an infusion and blood collection device that allows for clean blood collection from a patient via a previously installed catheter, wherein the patient is a pediatric patient, a hemophiliac patient, an HIV patient, a patient with dementia and / or a similar condition, and / or any patient who may be emotionally agitated or suffer from needle prick fear or has other increased risks associated with additional needle insertion.

[0024] Another object of the present invention is to provide an infusion and blood collection device that allows for clean blood collection from a patient via a previously installed catheter without the need for temporary interruption of drug or fluid administration and without performing a series of lengthy and cumbersome flushing steps to prevent accidental contamination of the blood sample by residual IV solution, drug, or fluid.

[0025] Another object of the present invention is to provide an infusion and blood collection device that allows for clean blood collection from a patient via a previously installed catheter in a manner that reduces the time and need for hospital staff to care for the patient.

[0026] This invention relates to a blood extraction device and method for use in conjunction with a pre-installed peripheral intravenous catheter / IV infusion line in a patient. The advantage of this device and method is that it enables blood extraction from the previously installed catheter without interrupting IV flow.

[0027] Another advantage of this device and method is the reduction in the number of venipunctures that must be performed on patients. This offers numerous potential benefits, such as reducing the potential for infection-causing events, reducing patient anxiety, reducing the time and need for hospital staff to care for patients, and reducing the disposal of biohazardous blood collection needle kits.

[0028] Another advantage is that the blood collection access port of the device is covered to prevent interference with the port and the transfer of bacteria from the external environment, which could contaminate or damage the port and potentially cause bodily harm.

[0029] An illustrative embodiment of an infusion and blood collection device for use with a patient catheter and an IV infusion line for providing IV therapeutic fluid to a patient includes: a blood collection component having an extraction inlet; a housing having an actuator and an IV infusion port coupled to the IV infusion line, the actuator activating at least an infusion / non-collection operating mode and an infusion / collection operating mode of the device; a microlumen juxtaposed with the patient catheter and in fluid communication with the IV infusion port; a blood collection channel in fluid communication with the catheter, the extraction inlet of the blood collection component being directly accessible to the blood collection channel; and wherein in the infusion / non-collection mode, the actuator fluidly connects the blood collection channel to the IV infusion port, and in the infusion / collection mode, the actuator fluidly isolates the blood collection channel from the IV infusion port.

[0030] In infusion / non-collection mode, the blood collection channel can be self-flushed using IV therapy fluid. The device may further include a passive restraint device that limits the volumetric flow rate of blood aspirated by the catheter in infusion / collection mode, thereby preventing the blood aspiration from mixing with the IV therapy fluid supplied through the microtubule lumen. The blood collection component may be releasably attachable to the housing. An actuator can be actuated to infusion / collection mode by engagement of the blood collection component with the housing, and actuated to infusion / non-collection mode by disengagement of the blood collection component from the housing. Engagement may include axial movement and rotational movement of the blood collection component relative to the housing, the axial movement positioning the aspiration inlet in fluid communication with the blood collection component and the rotational movement operating the actuator.

[0031] The extraction inlet may include a needle that can be positioned to extend into the blood collection channel in infusion / collection mode. The blood collection component may fluidly connect a vacuum blood collection tubing to the blood collection channel. The actuator may include a rotary valve. The rotary valve may be a two-way valve having two open ports and a third selective port, and the valve defines at least a portion of the blood collection channel. The extraction inlet of the blood collection component may be capable of extending through the third selective port into the portion of the blood collection channel defined by the rotary valve. A microlumen may extend beyond the distal end of the catheter, such that the distal end of the microlumen is positioned distally beyond the distal end of the catheter. The microlumen may coaxially extend through the catheter. The patient catheter may include a fluid catheter connector. The housing may include a fluid head connector for coupling to the catheter connector. The microlumen may exit the housing from within the head connector. The blood collection channel may be in fluid communication with the head connector.

[0032] Further illustrative embodiments of an infusion and blood collection device for use with a patient catheter and an IV infusion line for providing IV therapeutic fluid to a patient include: a blood collection component; a housing having an actuator and an IV infusion port coupled to the IV infusion line, the actuator at least activating an infusion / non-collection operating mode and an infusion / collection operating mode of the device; a microlumen juxtaposed with the patient catheter and in fluid communication with the IV infusion port; a blood collection channel in fluid communication with the catheter; and a passive restraint device that limits the volumetric flow rate of blood drawn from the catheter in the infusion / collection mode, thereby preventing the blood draw from mixing with the IV therapeutic fluid provided through the microlumen; and wherein in the infusion / non-collection mode, the actuator fluidly connects the blood collection channel to the IV infusion port, and in the infusion / collection mode, the actuator fluidly isolates the blood collection channel from the IV infusion port.

[0033] The passive restraint device may be a thin, elongated tube fluidly connecting the blood collection component and the blood collection channel. The microlumen may be coaxially positioned within the catheter, with its distal end extending distally beyond the distal end of the catheter. The blood collection component fluidly connects a vacuum blood collection tube to the blood collection channel. The blood collection component may be releasably attachable to a housing. An actuator can be actuated to an infusion / collection mode by engagement of the blood collection component with the housing, and can be actuated to an infusion / non-collection mode by disengagement of the blood collection component from the housing. Engagement may include axial movement and rotational movement of the blood collection component relative to the housing, the axial movement positioning the elongated tube in fluid communication with the blood collection component and the rotational movement actuating the actuator.

[0034] Another illustrative embodiment of an infusion and blood collection device for use with a patient catheter and an IV infusion line for delivering IV therapeutic fluid to a patient includes: a housing having an actuator and an IV infusion port coupled to the IV infusion line, the actuator at least activating an infusion / non-collection operating mode and an infusion / collection operating mode of the device; a microlumen coaxially positioned through the patient catheter, the distal end of the microlumen extending distally beyond the distal end of the catheter, and the microlumen being in fluid communication with the IV infusion port; and a blood collection channel in fluid communication with the catheter. And a blood collection tube holder that can be releasably attached to a housing and has an extraction needle that, in infusion / collection mode, is selectively in fluid communication with the blood collection channel and provides constraint: limiting the volumetric flow rate of blood extracted by the catheter in infusion / collection mode, thereby preventing the blood extraction from mixing with IV therapy fluid provided through the microtubule; and wherein, in infusion / non-collection mode, an actuator fluidly connects the blood collection channel to the IV infusion port, and in infusion / collection mode, the actuator fluidly isolates the blood collection channel from the IV infusion port. Attached Figure Description

[0035] For detailed explanation, please refer to the following attached figures:

[0036] Figure 1 This is a three-dimensional assembly diagram of a first illustrative embodiment of an infusion and blood collection device for use with IV infusion lines and peripheral venous catheters;

[0037] Figure 2A yes Figure 1 A schematic diagram of the fluid system of the device in the infusion / non-collection operation mode;

[0038] Figure 2B and Figure 2C yes Figure 1 A schematic diagram of the fluid system of the device in the infusion / collection operation mode;

[0039] Figure 3 yes Figure 1 An exploded perspective view of the valve housing portion of the device;

[0040] Figure 4 yes Figure 1 An exploded perspective view of the blood collection tube holder portion of the device;

[0041] Figure 5 yes Figure 1 Top 3D assembly diagram of the device before use;

[0042] Figure 6 yes Figure 1The bottom three-dimensional assembly diagram of the device before use, with the protective cap removed from the top of the microtubule;

[0043] Figure 7A It is placed together with the IV infusion line and peripheral venous catheter. Figure 1 A three-dimensional assembly diagram of the device in infusion / non-collection mode with the tube holder ready to be connected to the valve housing;

[0044] Figure 7B It is along Figure 7A The cross-sectional view shown is a section of the valve housing and the individual tube retainer cut along the cutting plane line 7B-7B, with the device in infusion / non-acquisition mode.

[0045] Figure 7C It is along Figure 7B The cross-sectional view shown is a section of the valve housing cut by the cutting plane line 7C-7C, and the device is in the infusion / non-acquisition mode.

[0046] Figure 8A yes Figure 1 A three-dimensional assembly diagram of the device, which is in infusion / non-acquisition mode and the tube holder is connected to the valve housing but has not yet rotated;

[0047] Figure 8B It is along Figure 8A The cross-sectional view shown is a section of the valve housing and the connected pipe retainer cut by the cutting plane line 8B-8B, and the device is in the infusion / non-acquisition mode.

[0048] Figure 8C It is along Figure 8B The cross-sectional view of the valve housing cut by the cutting plane line 8C-8C is shown, and the device is in the infusion / non-acquisition mode.

[0049] Figure 9A yes Figure 1 The three-dimensional assembly diagram of the device shows the device being actuated to infusion / collection mode, with the tube holder connected to the valve housing and rotated, and the blood collection tube connected to the tube holder.

[0050] Figure 9B It is along Figure 9A The cross-sectional view shown is a cut-out plane line 9B-9B of the valve housing, the connected pipe retainer, and the acquisition pipe, with the device in infusion / acquisition mode.

[0051] Figure 9C It is along Figure 9B The cross-sectional view of the valve housing cut by the cutting plane line 9C-9C is shown, and the device is in the infusion / collection mode.

[0052] Figure 10A yes Figure 1 The three-dimensional assembly diagram of the device shows that the device has returned to the infusion / non-acquisition mode and the tube holder has been rotated in the opposite direction and disconnected from the valve housing;

[0053] Figure 10B It is along Figure 10A The cross-sectional view shown is a section of the valve housing and the connected pipe retainer cut by the cutting plane line 10B-10B, and the device is in the infusion / non-acquisition mode.

[0054] Figure 10C It is along Figure 10B The cross-sectional view shown is a section of the valve housing cut along the cutting plane line 10C-10C, where the device is in the infusion / non-acquisition mode;

[0055] Figure 11 This is a perspective assembly diagram of a second illustrative embodiment of the infusion and blood collection device of the present invention, which is illustratively shown as being installed between an IV infusion line and a peripheral venous catheter.

[0056] Figure 12 yes Figure 11 A perspective view of the transport and acquisition components of the second embodiment of the device;

[0057] Figure 13 yes Figure 11 A perspective view of the catheter tip assembly of the second embodiment of the device;

[0058] Figure 14 yes Figure 11 Top perspective view of the delivery valve and the collection body of the second embodiment of the device;

[0059] Figure 15 yes Figure 11 A bottom perspective view of the acquisition tube holder of the second embodiment of the device;

[0060] Figure 16 yes Figure 11 Top perspective view of the delivery valve housing of the second embodiment of the device;

[0061] Figure 17 yes Figure 16 Top perspective view of the delivery valve housing, with the rotary valve actuator removed;

[0062] Figure 18 yes Figure 17 A semi-transparent top view of the delivery valve housing, showing the infusion and collection channels in the device;

[0063] Figure 19 yes Figure 17 A perspective view of the rotary valve and actuator of the delivery valve housing;

[0064] Figure 20 It is in infusion / non-collection mode. Figure 17 A semi-transparent top view of the delivery valve housing, and the diagram shows the IV flow in all channels;

[0065] Figure 21 It is in infusion / collection mode. Figure 17 A semi-transparent top view of the delivery valve housing, and the figure shows the IV flow in the IV channel and the blood flow in the blood collection channel;

[0066] Figure 22 It was cut along the cutting plane line 22-22. Figure 12 Cross-sectional view of the delivery valve housing and pipe retainer;

[0067] Figure 23 It was cut along the cutting plane line 23-23. Figure 13 A cross-sectional view of the catheter tip assembly;

[0068] Figure 24 It was cut along the cutting plane line 24-24. Figure 13 A cross-sectional view of the catheter tip assembly, showing the IV flow in the IV channel and the blood flow in the blood collection channel within the assembly;

[0069] Figure 25 yes Figure 24 An enlarged partial cross-sectional view of the tip of the catheter and microlumen, showing the tip of the microlumen extending beyond the tip of the catheter;

[0070] Figure 26 It is in infusion / non-collection mode. Figure 16 A transparent top view of the delivery valve housing, and the diagram shows the IV flow in all channels;

[0071] Figure 27 It was cut along the cutting plane line 27-27. Figure 26 A semi-transparent cross-sectional view of the delivery valve housing, showing the infusion / non-acquisition mode;

[0072] Figure 28 It is in infusion / collection mode. Figure 16 A transparent top view of the delivery valve housing, and the figure shows the IV flow in the IV channel and the blood flow in the blood collection channel;

[0073] Figure 29 It was cut along the cutting plane line 29-29. Figure 28 A semi-transparent cross-sectional view of the delivery valve housing, showing the infusion / collection mode;

[0074] Figure 30A It is along Figure 31A The section shown is cut along the cutting plane line 30A-30A. Figure 11 A cross-sectional view of the needleless extraction port of the device, wherein the device is in infusion / non-acquisition mode;

[0075] Figure 30B It is along Figure 31A The section shown is cut along the cutting plane line 30A-30A. Figure 11 A cross-sectional view of the needleless extraction port of the device in cooperation with the needleless extraction cannula, wherein the device is in infusion / collection mode.

[0076] Figure 31A yes Figure 11 Bottom axial view of the device's needleless extraction port, with the device in infusion / non-acquisition mode;

[0077] Figure 31B yes Figure 11 Bottom axial view of the device with the needleless extraction port cooperating with the needleless extraction cannula, wherein the device is in infusion / collection mode;

[0078] Figure 32 This is a three-dimensional assembly diagram of a third illustrative embodiment of an infusion and blood collection device used with an IV infusion line and a peripheral venous catheter;

[0079] Figure 33 yes Figure 32 An exploded three-dimensional view of the device;

[0080] Figure 34 It is along Figure 32 The cross-sectional view shown is a section cut along plane line 34-34, depicting the valve housing and individual tube retainer, with the device in infusion / non-acquisition mode.

[0081] Figure 35 It is along Figure 32 The cross-sectional view shown is a section cut along plane line 35-35, depicting the valve housing and individual tube retainer, with the device in infusion / non-acquisition mode.

[0082] Figure 36 It is along Figure 32 The cross-sectional view shown is a section of the valve housing and the connected pipe retainer cut by the cutting plane line 34-34, and the device is in the infusion / collection mode;

[0083] Figure 37 It is along Figure 32 The cross-sectional view shown is a section of the valve housing and the connected pipe retainer cut along the cutting plane line 35-35, with the device in the infusion / collection mode.

[0084] Figure 38 yes Figure 32 A side view of the extraction needle of the infusion and blood collection device;

[0085] Figure 39 yes Figure 32 A three-dimensional view of the extraction needle of the infusion and blood collection device;

[0086] Figure 40 yes Figure 32 A view of the end of the extraction needle in an infusion and blood collection device;

[0087] Figure 41 yes Figure 32 A three-dimensional view of the septum of the infusion and blood collection device;

[0088] Figure 42 yes Figure 32 Side view of the septum of the infusion and blood collection device;

[0089] Figure 43 yes Figure 32 A cross-sectional view of the septum of the infusion and blood collection device;

[0090] Figure 44 yes Figure 32 End view of the septum of the infusion and blood collection device;

[0091] Figure 45 yes Figure 32 A three-dimensional view of the bottom front of the shunt valve of the infusion and blood collection device;

[0092] Figure 46 yes Figure 32 A three-dimensional view of the bottom rear of the shunt valve of the infusion and blood collection device;

[0093] Figure 47 It is along Figure 32 The cross-sectional view of the valve housing taken by cutting plane line 34-34 is shown.

[0094] Figure 48 It is along Figure 35 The cross-sectional view shown is a section of the valve housing cut by plane line 48-48, in which the device is in the injection / non-acquisition mode;

[0095] Figure 49 It is along Figure 35 The cross-sectional view shown is a section of the valve housing cut by plane line 48-48, in which the device is in injection / collection mode;

[0096] Figure 50 It is along Figure 32 The cross-sectional view shown is taken from the cutting plane line 34-34, which is the cross-sectional view of the valve housing, Luer lock, conduit and conduit head;

[0097] Figure 51 It is along Figure 32 The section shown is cut along plane line 34-34, which includes the microtubule. Figure 50 The cross-sectional view of the valve housing shown; and

[0098] Figure 52 yes Figure 32 End view of the valve housing of the infusion and blood collection device. Detailed Implementation

[0099] To facilitate understanding of the principles of this disclosure, reference will now be made to one or more embodiments, which may or may not be shown in the accompanying drawings, and will be described using specific language. However, it should be understood that this is not intended to limit the scope of the disclosure; any changes and other variations to the described or illustrated embodiments, and any other application of the principles of the disclosure illustrated herein, are contemplated, as would normally occur to those skilled in the art to which this disclosure pertains. At least one embodiment of the disclosure has been shown in great detail, but it will be apparent to those skilled in the art that some features or combinations of features may not be shown for clarity.

[0100] Any reference to "invention" in this document refers to a series of embodiments of the invention, and unless otherwise stated, no single embodiment includes features that must be included in all embodiments. Furthermore, while some benefits or advantages provided by certain embodiments may be mentioned, other embodiments may not include those same benefits or advantages, or may include different benefits or advantages. Any benefits or advantages described herein should not be construed as limiting any of the claims.

[0101] Similarly, the "objectives" associated with some embodiments of the invention may be discussed; it should be understood that other embodiments may not be associated with those same objectives, or may include different objectives. Any advantages, objectives, or similar terms used herein should not be construed as limiting any claim. The use of terms indicating preference, such as "preferred," refers to features and aspects present in at least one embodiment but optional for some embodiments.

[0102] Specific quantities (spatial dimensions, temperature, pressure, time, force, resistance, current, voltage, concentration, wavelength, frequency, heat transfer coefficient, dimensionless parameters, etc.) may be used explicitly or implicitly herein, unless otherwise stated, and are presented by way of example only and are approximate values. Unless otherwise stated, discussions of specific material compositions (if any) are presented by way of example only and do not limit the applicability to other material compositions, especially those with similar properties.

[0103] Refer to the attached figures. Figure 1-Figure 1 These figures illustrate a first illustrative embodiment of an infusion and blood collection device, system, and / or method 100 of the present invention. The device 100 is illustratively shown as being coupled in use between a standard IV infusion line 10 and a standard catheter 20 (e.g., a peripheral venous catheter placed in a vein in a patient's arm or hand). An example of such a standard catheter 20 is the Protective IV catheter, product number 381534, also known as the BD InsyteAutoguard Winged20 gauge catheter, available from Becton, Dickson and Company (BD), of Sandy, Utah.

[0104] It should be understood that, in typical cases requiring intravenous catheterization, such as in an emergency room or hospital, the IV infusion line 10 and catheter 20 are directly connected together via a releasable fluid connector, typically a Luer lock type connector, having a convex portion (not shown) at the proximal end 24 of catheter 20 and a concave connector portion 11 at the proximal end 12 of the IV infusion line. The IV infusion line 10 is typically connected at its opposite distal end to an IV treatment bag (not shown) and / or an infusion pump (not shown), and the distal end 22 of catheter 20 is inserted, for example, using a sharp insertion needle inserter (not shown), into, for example, an IV infusion line 10. Figure 1 and Figures 2A-2C The needle of the needle inserter is inserted into a patient's blood vessel in the arm or hand of the patient, extending through catheter 20 and beyond the distal end 22 of catheter 20, and is removed from catheter after the distal end is placed into the patient's vein 23. An example of such an inserter is product number 384010, available from BD Corporation of Sandy, Utah, also known as the BD Insyte Autoguard Shielded inserter. After placement of catheter 20, the infusion and blood collection device 100 of the present invention is simply installed between IV infusion line 10 and catheter 20 via connectors 11 and 65, as discussed below.

[0105] An illustrative embodiment of the infusion and blood collection device 100 of the present invention includes... Figure 1 , Figure 3 and Figure 6 The following main components are depicted: a collection tube holder 30 for receiving a standard vacuum collection tube 15; a valve housing 40 that closes a valve 80 and includes an intravenous infusion (IV) inlet 43 and a catheter tip 63; a cannula 70 for connecting the tube holder 30 to the valve housing 40; and an optional retaining support 90 for securing the IV infusion line 10 and the valve housing 40 to the patient's arm.

[0106] Materials that can be used to form the tube retainer 30, valve housing 40, sleeve 70, valve 80, and retaining support 90 include, for example, medical-grade plastics and structural polymers such as ABS, polyurethane, polycarbonate, PBT, PEI, PEEK, polypropylene, PET, etc. For example, the tube retainer 30, valve housing 40, and sleeve 70 can be formed of polycarbonate, and the valve 80 can be formed of polypropylene.

[0107] The intravenous infusion port 43 includes a separate or integrally formed convex connector 42 for fluid connection with a concave connector 11, such as a Luer lock fitting, to the IV infusion line 10. The catheter tip 63 includes a concave connector 65, such as a Luer lock fitting, for fluid connection with the catheter 20. The catheter tip 63 also includes an intravenous infusion microtubule 60 fluidly connected to the IV infusion channel 58 and the blood collection channel 54, and the outlet 64 of the catheter tip 63 is fluidly connected to the catheter 20. Figure 6 and Figure 7C ).

[0108] Figures 2A-2C A schematic diagram of an illustrative fluid system 101 according to an apparatus 100 of the present invention is shown. Referring to the apparatus 100, a blood collection channel 54 and an infusion channel 58 extend between an IV inlet 43 and a catheter tip 63. As described above, the catheter tip 63 is coupled to an IV catheter 20 previously placed in a patient's peripheral vein 23, and the catheter tip 63 also includes a microlumen 60. When the catheter tip 63 is coupled to the connector 24 of the catheter 20, the microlumen 60 is coaxially inserted into the interior of the catheter 20. For reasons described more fully below, the relative lengths of the catheter 20 and the microlumen 60 are such that the distal end 62 of the microlumen 60 extends distally beyond the distal end 22 of the catheter 20, thereby extending axially further along and within the patient's vein 23, such as... Figure 2C As shown. The microtubule 60 is in fluid communication with the infusion channel 58. The catheter 20 (or more precisely, the radial space between the outer surface of the microtubule 60 and the inner surface of the catheter 20 for device 100) is in fluid communication with the blood collection channel 54 via the outlet 64. Figure 6 and Figure 7CIt has been found that a microlumen 60 having at least a minimum amount of rigidity while maintaining sufficient flexibility to be securely held within the catheter 20 and vein 23 is advantageous in allowing the microlumen 60 to pass through the connector 24 and catheter 20. For example, microlumens formed of unbraided and uncoated polyimide have been found to have acceptable properties. As another example, microlumens formed of unbraided and coated polyimide (such as product code 165-111 available from Microlumen of Oldsmar, FL) have been found to have acceptable properties. And as yet another example, microlumens formed of braided and coated (or uncoated) polyimide may also have acceptable properties.

[0109] Advantageously, device 100 provides selective operation in both infusion / non-collection mode and infusion / collection mode. For example... Figure 2A As shown, in infusion / non-collection mode, IV fluid 14 (i.e., any fluid entering the body) is simultaneously supplied from IV inlet 43 to each of the infusion channels 58 (including microtubules 20) and blood collection channels 54 (including catheters 20) of the fluid system 101. In infusion / non-collection mode, IV fluid 14 flows into the fluid system at IV inlet 43 and simultaneously exits at the corresponding distal ends 22 and 62 of catheters 20 and microtubules 60 into vein 23.

[0110] In comparison and as Figure 2B and Figure 2C As shown, in the infusion / collection operation mode, the blood collection channel 54 of device 100 is isolated from the IV inlet 43 and therefore from the supply source of IV fluid 14. Fluid isolation between the IV inlet 43 and the blood channel 54 can be achieved by any of the various mechanical or electromechanical actuators known in the art. For example, in the illustrative first embodiment of device 100, a three-port (including a selectively sealed extraction port 81) two-way rotary valve 80 ( Figure 3 Rotate from the non-collection valve position 83a to the collection valve position 83b. In the non-collection valve position, valve passage 84a ( Figure 2A and Figure 7C The valve passage 84a is fluidly connected to both IV inlet 43 and blood channel 54. In the collection valve position, the valve passage 84a... Figure 2B and Figure 9C It is fluidly isolated from IV inlet 43 but remains fluidly connected to blood passage 54. Valve passage 84a thus forms part of blood collection passage 54 in valve position 83b. As used herein, "actuator" (an example of which is "valve") means a device that affects the flow of fluid, such as starting, stopping, or otherwise regulating the flow of fluid.

[0111] like Figure 2B As shown, once the blood collection channel 54 is isolated from IV fluid 14, a vacuum blood collection tube is fluidly connected to the blood collection channel 54 via an outlet, such as needle channel 84b. The vacuum in the collection tube 15 draws blood 18 into the catheter 20, or more precisely, from... Figure 2C The space between the catheter 20 and the microtubule 60 shown passes through the blood collection channel 54 and enters the collection tube 15. The collection of blood 18 and the infusion of IV treatment fluid 14 through the infusion channel 58 (which exits at the distal end 62 of the microtubule 60 and enters the patient's vein 23) occur simultaneously and without interruption.

[0112] When blood 18 is drawn from vein 23 into catheter 20, the fluid entering collection tube 15 will initially be IV fluid 14, then a mixture of IV fluid 14 and blood 18, and then only blood 18. Therefore, the first collection tube 15 filled through blood collection channel 54 is discarded, and subsequently filled blood collection tubes 15 containing only blood 18 and not IV fluid 14 are retained. After obtaining a sufficient sample of blood 18 from device 100, collection tube 15 is disconnected from blood collection channel 54, and if necessary, subsequent collection tubes 15 are connected, filled, and disconnected, and then rotary valve 80 is returned to non-collection valve position 83a, reconnecting blood collection channel 54 to therapeutic fluid 14 from IV inlet 43, thereby providing again... Figure 2A In the infusion / non-collection mode, IV fluid 14 is simultaneously supplied to both the catheter 20 and the microlumen 60.

[0113] refer to Figure 2C The distal end 62 of the microtubule 60 is shown extending distally from the distal end 22 of the catheter 20. The length of the distal portion 62 of the microtubule 60 extending from the distal end 22 of the catheter 20 is schematically about 10 mm, but this length can vary depending on the different fluid dynamic characteristics of the device 100, including the type and model of the catheter 20 and the microtubule 62 used, and the desired blood collection flow rate. As will be seen from the following discussion, the extension length and blood collection flow rate are of significant importance to the invention herein in order to prevent the drawn blood 18 from mixing with the IV fluid 14 at the distal end 22 and thereby prevent the drawn blood from being contaminated by the IV fluid. For example, a typical IV catheter 20 is 18 or 20 gauge, and the microtubule 60 providing the required functionality when axially inserted into the catheter 20 is about 24 to 25 gauge.

[0114] refer to Figure 3An exploded perspective view of the valve housing 40 is shown. The valve housing 40 includes a housing top 44 and a housing bottom 45 that together define a valve cavity 50, IV infusion passage portions 58a and 58b, and a blood collection passage 54. The valve housing 40 provides continuous fluid communication through the infusion passage 58a, thereby continuously supplying IV fluid 14 present at the IV inlet 43 to each of the outlet 64 and the microtubule 60. The valve cavity 50 hermetically houses a rotary valve 80 that selectively supplies IV fluid 14 to the blood collection passage 54 in a non-collection operation mode. For example, the valve member 82 may include a sealing ridge or other feature 85 to prevent fluid leakage, and the valve member 82 and / or the valve cavity 50 may be coated with a sealing material and / or lubricating material, such as silicone spray or gel, or may include an elastomeric sealing layer prior to assembly.

[0115] Rotary valve 80 includes a valve member 82 defining a valve passage 84a, the valve passage having an opening connected to the opposite side of the valve housing. Figure 3 and Figure 7C Valve member 82 further defines extraction port 81 and pipe retainer engagement features 86 and 87, which will be further described below. The extraction port is defined by septum 76. Figure 3 The fluid blocks and maintains the septum.

[0116] The extraction port 81, located at the bottom 77 of the diaphragm 76, is accessible via the needle passage 84b. Figure 7B Fluid connection to valve passage 84a. (Reference) Figure 7B and Figure 7C When valve 80 is closed within the assembled housing top 44 and housing bottom 45 and valve 80 is in the non-collection position 83a ( Figure 7C When the infusion passage 84a of valve 80 fluidly connects the infusion channel portion 58b to the blood collection channel 54, thereby supplying IV fluid 14 to the catheter tip 63 and catheter 20. (Reference) Figure 9C When valve 80 is rotated to the collection position 83b, the valve passage 84a of valve 80 is fluidly isolated from the infusion passage portion 58b, but remains in fluid communication with the blood collection passage 54, thereby providing a path for supplying blood 18 entering the distal end 22 of catheter 20 to valve passage 84a, needle passage 84b and bottom 77 of septum 76.

[0117] refer to Figure 4 The collection tube holder 30 provides an adapter for connecting the blood collection tube 15 to the valve housing 40, and also serves as a non-collection position 83a corresponding to the infusion / non-collection operation mode. Figure 8C ) and the acquisition position 83b corresponding to the infusion / acquisition operation mode ( Figure 9CThe valve 80 is actuated between the tubes. The tube holder 30 includes an insertion and rotation handle 31, a central tube receiver 32, a tube stop 33 at the base of the receiver, a withdrawal port interface 36, and a withdrawal needle 34. (See reference) Figure 7B The extraction needle 34 extends through the tube stop 33 and has a tip 34a extending above the tube stop 33 and upward into the tube receiver 32. The extraction needle 34 also extends downward below the tube stop 33 and extends within a central region 39 enclosed by the extraction port interface 36. The extraction port interface 36 partially serves to surround the sharp lower end 34b of the needle 34 and prevent damage from this lower end.

[0118] The tube retainer interface 36 is configured to fit within an opening 46 in the valve housing 40 and engages with the valve 80 and housing 40 when the tube retainer 30 and sleeve 70 are coupled to the valve housing 40. In a first illustrative embodiment of the device 100, the engagement of the tube retainer 30 with the valve housing 40 and valve 80 provides axial positioning of the extraction needle 34 and rotation of the valve 80. More specifically, this engagement allows the extraction needle 34 to extend axially through the septum bottom 77 and needle channel 84b and into the valve passage 84a, as... Figure 9B As shown. Furthermore, this engagement rotates valve 80 and valve housing 40 from the inlet / non-collection valve position 83a to the inlet / collection valve position 83b. Optionally, mechanical features may be provided to the tube retainer 30, housing 40, and / or valve 80 to provide mechanical braking or other sensing feedback indicating the limits of full rotation and / or axial translation to ensure proper use and operation.

[0119] refer to Figure 3 , Figure 4 and Figure 7B The tube retainer interface 36 defines different engagement features, including an axial extraction protrusion 37, a rotating slot 38, and a central region 39. The valve housing 40 defines different engagement features, including an opening 46, an extraction protrusion receiving portion 47, and an extraction ramp 48. The valve 80 defines different engagement features, including a receiving portion 86 and a rotating tooth 37. The function and interaction of the different engagement features will be further described below in the operation of the device 100.

[0120] Figures 7A-7C , Figures 8A-8C , Figures 9A-9C as well as Figures 10A-10C The series illustrates different steps and stages of the infusion / non-collection operation mode: preparing device 100 for blood aspiration, drawing blood into one or more collection tubes 15 in the infusion / collection operation mode, and returning device 100 to the infusion / non-collection operation mode.

[0121] refer to Figure 7AIn the following illustrative use of the illustrative device 100, the installation of the infusion and blood collection device 100 for intravenous therapy of a patient is described. Prior to installation of the device 100, following standard techniques well known in the art, a peripheral venous catheter 20 is typically inserted into the patient's vein and connected to the IV therapy tubing 10 via a Luer-type or other connector 11. To mount the infusion and blood collection device 100 in a straight line with the catheter 20 so that clean blood samples can be periodically drawn from the patient via the catheter 20, the IV therapy fluid flow 14 through the IV infusion line 10 is stopped, and the peripheral venous catheter 20 is disconnected from the IV infusion line 10. By connecting connector 11 to inlet port 43, the valve housing 40 of the device is connected to IV infusion line 10. Fluid flow 14 through IV infusion line 10 is then restarted, and IV fluid 14 (or, for example, heparin) flowing into inlet port 43 fills both blood collection channel 54 and infusion channel 58 in housing 40 until IV fluid 14 flows out from catheter tip 63, thereby expelling all air from channels 54 and 58. The protective cap 96 can be activated by, for example, an actuated release element 98. Figure 5 Remove from catheter tip 63 to expose microtubule 60.

[0122] The catheter tip 63 can then be attached to the catheter 20 (which is, for example, already held in the patient's body) by inserting a through-catheter 20 into the microlumen 60 and securing a Luer type or other connector 65 to the convex catheter connector 63, thereby allowing IV therapeutic fluid 14 to be infused into the patient from both the catheter 20 and the microlumen 60. Advantageously, the valve housing 40 can be grasped from above and held in the palm of the hand, while the actuation of the release element 98, the guiding of the microlumen 60, and the rotation of the connector 65 via the flap 66 are all performed using the free thumb and / or forefinger of the hand grasping the valve housing 40, thus freeing the other hand to apply pressure to the vein 23 to prevent blood flow through the catheter 20 from disconnecting the IV line connector 11 to the connector 65 of the connecting device 100. Figure 1 The optional retaining support 90 shown is connected to the valve housing receiving portion 94 at the clamp 92. Figure 3 In the event of a situation where medical tape can be applied to surface 91 and around the patient's arm, the valve housing 40 can be held in place. Advantageously, the valve housing 40 may include a ridge or other protrusion defined by the bottom 45 of the housing to limit the risk of skin contact or skin abrasion. Furthermore, in order to allow any fluid drainage that might enter the opening 46 if the tube retainer 30 is not in place and to minimize the possibility of microbial growth, a drainage channel 51 extending downward from within the opening 46 may be defined through the housing 40.

[0123] Alternatively and advantageously, the device 100 may be installed in a straight line with the catheter 20 during initial placement of the catheter 20 and before the IV infusion line 10 is connected to the catheter 20. For example, as described above, the device 100 may be connected to the IV infusion line 10 and air may be flushed out using IV fluid 14. Then, with the device 100 ready, the peripheral venous catheter 20 may be placed into the patient's vein, and the catheter tip 63 may be attached to the catheter 20, as described above.

[0124] Now for reference Figures 7A-7C The device 100 is shown in an infusion / non-sampling operation mode after being installed in a straight line with IV line 10 and conduit 20. Specifically, the tube retainer 30 and sleeve 70 are disconnected from valve housing 40, and rotary valve 80 is in the infusion / non-sampling rotary position 83a. Figure 7C In this infusion / non-collection rotation position, IV fluid 14 provided at inlet 43 is simultaneously supplied to each of the blood collection channel 54 and the infusion channel 58a, and thus simultaneously flows from each of the catheter 20 and the microlumen 60 into the patient's vein 23.

[0125] To prepare the device 100 for infusion / collection operation mode, clean the area within the septum 76 and opening 46 with alcohol swabs or other sterile swabs to remove any contaminants. Next, attach the tube holder 30, to the valve housing 40, before the blood collection tube 15 is attached. Specifically, rotatably align the axial extraction protrusion 37 with the extraction protrusion receiving portion 47, and... Figure 7A and Figure 7B The tube retainer 30 is moved vertically downward in the direction shown, thereby engaging the protrusion 37 through the receiving portion 47 and into the extraction ramp 48, and engaging the side flange 72 around the valve housing 40. The sleeve 70 and tube retainer 30 are releasably held to the valve housing 40 by engaging the protrusion 71 into the recess 41 located on each side of the valve housing 40. Furthermore, and as... Figure 8B and Figure 8C As shown, in this position, the lower end 34b of the extraction needle 34 has not yet penetrated the septum 76 and the rotary valve 80 remains in the infusion / non-collection rotary position 83a. Figure 8A As shown, flange 72 may define friction elements, such as ridges, to help securely hold device 100 in subsequent steps.

[0126] To facilitate the axial translation of the lower end 34b of the extraction needle 34 through the diaphragm 76 and into the valve passage 84a, the tube holder 30 is rotated clockwise relative to the valve housing 40, as follows: Figure 8A As shown. Now referring to the device 100 that completes the rotation is shown. Figure 9B and Figure 9CThe rotation of the tube retainer 30 causes the extraction protrusion 37 to rotate within the extraction ramp 48 of the housing 40. The extraction ramp 48 forms a downward spiral, causing the rotation to further axially and downwardly translate the tube retainer interface 36 into the valve housing 40, reaching... Figure 9B As shown, in this position, the lower end 34b of the extraction needle 34 pierces the septum 76 and extends into the valve passage 84a. Furthermore, because the insert 87 is engaged within the slot 38 of the interface 36, the interface 36 rotates with the rotation of the tube retainer 30, causing the valve 80 to rotate. This rotation causes the valve 80 to... Figure 9C As shown in the infusion / collection position 83b, in the infusion / collection position, valve passage 84a ( Figure 2B and Figure 9C It is fluidly isolated from IV inlet 43 but remains fluidly connected to blood channel 54. A mechanical stop (not shown), such as the end of the extraction ramp 48 contacted by extraction protrusion 37, prevents valve 80 from excessively rotating in the clockwise and counterclockwise directions.

[0127] Optionally, the initial length of the extraction ramp 48, defined in the valve housing 40 and engaged by the extraction protrusion 37, can extend circumferentially without axial downward displacement, so as to provide some or complete rotation of the valve 80 before the subsequent axial translation of the interface 36 and the needle 34, thereby ensuring that there is no fluid connection between the lower end of the needle 34b and the valve passage 84a before the valve passage 84a is isolated from the infusion passage portion 58b and thus from the supply source of IV fluid 14.

[0128] like Figure 9A and Figure 9B As shown, once the blood collection channel 54 is isolated from IV fluid 14, the vacuum blood collection tube 15 is fluidly connected to the blood collection channel 54 via needle channel 84b and valve passage 84a. More specifically, as the collection tube is pushed down into the tube receiver 32 and abuts against the tube stop 33 of the tube holder 30, the septum 16 of the collection tube 15 pushes down the elastomeric needle cap 35, thereby exposing the upper end 34a of the needle to allow the upper end of the needle to pierce the collection tube septum 16. The vacuum of the collection tube 15 draws blood 18 into the catheter 20, as... Figure 2C As shown, the blood passes through the blood collection channel 54, valve passage 84a, needle 34 and enters the collection tube 15.

[0129] Advantageously, the collection of blood 18 and the infusion of IV therapeutic fluid 14 through the infusion channel 58, exiting at the distal end 62 of the microtubule 60, and entering the patient's vein 23 occur simultaneously and without interruption of the infusion. The collection tube 15 is disconnected from the tube holder 30, and, if necessary, a subsequent collection tube 15 is connected, filled, and disconnected. Without the collection tube 15 in place, blood 18 will stop flowing through the needle 34 due to the lack of vacuum, the passive fluid flow constraint provided by the needle 34, and the elastomer cap 35 re-covering the upper end 34a of the needle 34. Flow constraint can be provided, for example, by selecting a needle 34 with a specific ID as described below, clamping the needle 34 to a specific desired cross-sectional area, or by other mechanical passive means known in the art for restricting flow.

[0130] To return device 100 to infusion / non-acquisition operation mode, such as Figure 10B and Figure 10C As shown, rotate the tube retainer 30 counterclockwise to separate the sleeve 70 and the tube retainer 30 from the valve housing 40, as... Figure 10A As shown. Rotating the tube holder 30 counterclockwise returns the rotary valve 80 to the non-collection valve position 83a, thereby reconnecting the blood collection channel 54 to the treatment fluid 14 from the IV inlet 43.

[0131] Rotating the tube holder 30 counterclockwise also causes the interface 36 and needle 34 to move axially upwards as the extraction protrusion 37 spirals upwards within the extraction ramp 48. When the extraction protrusion 37 aligns with 47 again, the rotation is complete, and the interface 36 can be fully removed from the opening 46, and the flange 72 can be removed from above the valve housing 40, as shown below. Figure 10B As shown. Advantageously, the septum 76 is self-sealing, so that when the needle 34 is removed and IV fluid 14 flows through the valve passage 84a, there is no overflow at the septum 76.

[0132] Similarly in Figure 10C In the infusion / non-collection mode shown, IV fluid 14 is again simultaneously supplied to both catheter 20 and microlumen 60, thereby flushing away the blood 18 previously drawn into blood collection channel 54 and allowing continued use of device 100. Thus, advantageously, blood collection channel 54 (including valve passage 84a) is self-flushing because returning to infusion / non-collection mode utilizes the flow of IV fluid 14 to flush away any residual blood passing through catheter 20, thereby preventing any clotting and potential blockage or other hazards of blood 18 associated with device 100. Because the extraction needle 34 associated with tube retainer 30 is not flushed, it is discarded and a new tube retainer 30 is used when another blood draw from the patient is required.

[0133] One aspect of a first embodiment of the invention relates to one of a number of novel features of the infusion and blood collection device 100 and method, which is the ability to perform clean blood collection while providing IV therapeutic infusion to a patient without interrupting the IV fluid flow. In one aspect, the device 100 is designed to prevent the blood 18 being drawn from being contaminated by the IV fluid 14. The ability of the device 100 to provide this functionality is due in part to two features of the device: 1) the tip of the microtubule 60 extends in the vein 23 beyond the optimal minimum distance of the tip of the catheter 20 (see [link to relevant documentation]). Figure 2C 2) Relevant constraints on the flow of blood 18 collected when the rotary valve 80 is rotated to the collection position 83b.

[0134] In illustrative embodiments of these foregoing features, for example, the distal tip 62 of the microtubule 60 extends beyond the distal tip 22 of the catheter 20 by 10 mm. Correspondingly, the constraint on the blood collection channel 54 reduces the blood collection flow rate to 30 ml / min or less. This allows sufficient prevention of IV fluid 14 flowing from the distal tip 62 of the microtubule 60 from being drawn toward and mixed with the blood 18, which is drawn into the distal tip 22 of the catheter 20 for collection in the collection tube 15.

[0135] As envisioned in this paper, it should be understood that the length of the microtubule protruding from the catheter tip and the degree of constraint on blood flow 18 can vary depending on various factors, such as the specific gauges of the catheters 20 and 60 used, the vacuum pressure in the specific collection tube 15, the venous or arterial location of catheter 20 in the patient, and the infusion rate at which the IV therapeutic fluid 14 leaves the microtubule 60. Therefore, for example, when the protrusion length is less than 10 mm, the flow rate must be further constrained and reduced accordingly, and when the protrusion length is greater than 10 mm, the flow rate can be increased accordingly.

[0136] Regarding the constraint of blood flow 18 to reduce the blood collection flow rate to a level that prevents IV fluid flow from reversing in the vein and being drawn into the blood collection tube, this constraint can be achieved by an active constraint device, a passive constraint device, or a combination of active and passive constraint devices in various ways known in the art and at different locations along the flow path of blood 18 between the distal end 22 of the catheter 20 and the blood collection tube 15. In the above illustrative embodiment of device 100, the constraint of the flow rate is passively performed by selecting the ID and length of the penetrating needle 34 penetrating the end of the collection tube, thus selecting a needle with an inner diameter narrow enough to provide the required restriction on the blood flow rate. In the illustrative device 100, where the distal end 62 of the microlumen 60 extends beyond the distal end 22 of the catheter 20 by 10 mm, the constraint limiting the flow rate to approximately 30 ml / min provides the desired uncontaminated collected blood sample. This required constraint is passively provided by using a penetrating needle 34 with approximately 24 gauges, for example, with an ID of approximately 0.3 mm (0.012 inches). For example, such a needle 34 can be cut from a section of stainless steel 304 circular infusion tubing material, for example, part number B00137QIWS available from Amazon.com, LLC, of ​​Seattle, Washington.

[0137] The volumetric flow rate (Q) of blood 18 is driven by the pressure change (ΔP) of the blood 18 at the point of passive constraint in the blood flow 18, namely at the extraction needle 34, between the patient and the collection tube 15 (and most notably in the illustrative embodiment of device 110). To specify a needle gauge that will limit the volumetric flow rate (Q) to a desired value, such as approximately 30 ml / min or less for this illustrative embodiment, the fluid dynamics principles for laminar flow (with applied forces and no-slip boundary conditions) can be used between the desired blood volumetric flow rate (Q) and the pressure gradient (ΔP). This relationship is expressed in the Hagen-Poiseuille equation Q = πa⁴ΔP / 8ρμL, where a, L, ρ, and μ in this example are the inner diameter and length of the needle 136, and the density and viscosity of the blood, respectively.

[0138] Refer to the attached figures. Figure 11 and Figure 13These figures illustrate a perspective view of a second illustrative embodiment of the illustrative infusion and blood collection device 110 of the present invention, illustratively mounted between a standard IV infusion line 10 and a standard catheter 20, such as a peripheral venous catheter. An example of such a standard catheter 20 is the Protective IV Catheter Product No. 381703, available from BD Corporation of Sandy, Utah, also known as the BD AngiocathAutoguard 20 gauge.

[0139] An illustrative embodiment of the infusion and blood collection device 110 of the present invention includes... Figure 11 The following are the main components depicted: a collection tube holder 120 for receiving a standard vacuum collection tube 15, a delivery valve and collection body 140, and an intravenous infusion port 143 for fluid connection with the IV infusion line 10. Figure 12 The catheter 20 includes a blood collection lumen 150, an intravenous infusion lumen 160, and a catheter tip assembly 200 for fluid connection with the catheter 20. The blood collection lumen 150 and the intravenous infusion lumen 160 connect the catheter tip assembly 200 to the delivery valve and the collection body 140.

[0140] Figure 12 The assembly of the tube holder 120, vacuum collection tube 15, delivery valve, and collection body 140 is shown. Figure 13 A catheter tip assembly 200 is shown, including a catheter tip body 202. The distal end of the catheter tip body 202 includes a connector 83 for attachment at the proximal end 24 of a standard intravenous catheter 20. Figure 23 The connector 204. In addition, the catheter tip assembly 200 includes an attached microtubule 210 that coaxially passes through the interior of the catheter 20.

[0141] The catheter head body 202 provides fluid connections between the microtubule 210 and the blood collection lumen 150, and between the catheter 20 and the intravenous infusion lumen 160. Figure 23 This is a cross-sectional side view of the catheter tip assembly 200, illustrating the internal passages 250 and 260 defined by the body 202. The blood collection passage 250 maintains the blood collection lumen 150 and is in fluid communication with both the blood collection lumen 150 and the catheter 20 (or more precisely, the open space between the interior of the catheter 20 and the exterior of the microtubule 210). The infusion passage 260 maintains the intravenous infusion lumen 160 and is in fluid communication with both the intravenous infusion lumen 160 and the microtubule 210.

[0142] The blood collection channel is partially defined by the space between catheter 20 and microlumen 210, passage 250, and lumen 150. The infusion channel is partially defined by microlumen 210, passage 260, and lumen 160. As will be discussed in more detail below, when device 110 is in infusion / non-collection mode, blood collection channel 152 is used to provide infusion flow to the patient, and as will be discussed below, when device 110 is in infusion / collection mode, blood collection channel is used to allow blood 18 to flow in reverse from the patient to collection tube 15. On the other hand, infusion channel 162 is used only for unidirectional infusion flow to the patient in either mode, as will be discussed below.

[0143] refer to Figures 23-25 The distal end 212 of the microtubule 210 is shown as extending distally from the distal end 22 of the catheter 20. Figure 25 This is an enlarged partial view of the distal tip portion 22 of catheter 20, and shows more clearly the protruding distal portion 212 of the microlumen 210. The length of the distal portion 212 of the microlumen 210 protruding from the distal end 22 of catheter 20 is illustratively about 10 mm, but this length can vary depending on the type and model of catheter used and the desired blood collection flow rate. The protrusion length and blood collection flow rate are of significant importance to the invention herein in order to prevent the drawn blood 18 from mixing with IV fluid 14 and thereby prevent contamination of the drawn blood by IV fluid 14, as will become apparent from the following discussion. For example, catheter 20 is typically a 18 or 20 gauge, which allows a flow rate of about 65-100 ml / min, although the flow rate will vary with the inner diameter. The microlumen 210, which provides the required functionality when axially inserted into catheter 20, is about a 25 to 26 gauge.

[0144] Figure 11 and Figure 13 Also shown is the catheter tip assembly 200, including the microlumen stabilizer pull handle 206 (from...). Figure 23 and Figure 24 (Omitted in the view shown). A pull handle 206 is connected to a thread or pin (not shown) inserted through the interior of the microtubule 210, thereby rigidifying the microtubule 210 and catheter 20 to allow the respective distal ends 212 and 22 to be inserted into the patient. After successful insertion, the pull handle 206 is actuated proximally along its axis to remove the thread or pin (not shown) from the interior of the microtubule 210, thus reducing rigidity. It should be understood that catheter insertion techniques may follow standard techniques well-known in the art for catheter insertion.

[0145] Refer again Figure 12 The figure shows a close-up perspective view of the assembled tube holder 120, vacuum collection tube 15, delivery valve, and collection body 140. Figure 14 and Figure 15 The delivery valve, the collection body 140, and the tube holder 120 are shown separately. Figure 15 A perspective view of the bottom side of the tube holder 120 is shown. The delivery valve and the collection body 140 enclose the delivery valve housing 142 (see below). Figure 16 The delivery valve housing includes valve assembly 180 (in Figure 19 (shown in part and discussed in more detail below), and a locking interface having a keyed opening 141a and a retaining flange 141b for positioning and retaining the tube retainer 120 relative to the valve assembly 180. Specifically, a retaining flap 122 (which is radially projecting from the actuator receiver 124 on the bottom of the tube retainer 120) Figure 15 The tube holder 120 is received through the key opening 141a, and while the tube holder 120 is rotating relative to the delivery valve and the collection body 140, the retaining vane 122 rotates below the retaining flange 141b to securely hold the tube holder 120 to the delivery valve and the collection body 140.

[0146] refer to Figure 14 , Figure 19 , Figure 22 , Figure 27 and Figure 29 The valve assembly 180 includes a rotary valve 182, a valve actuator 184, an elastomeric valve layer 190, and a portion of a housing top 144. The actuator 184 is spaced apart from the rotary valve 182 and rotatably fixed to the rotary valve 182 via a central shaft 181. The elastomeric valve layer 190 and the portion of the housing top 144 are fixed relative to the housing 140 and therefore do not rotate with the rotary valve 182, the actuator 184, and the shaft 181. The actuator 184 (… Figure 14 and Figure 16 The following opening is defined: the opening includes a latch lug 148 that receives the latch in an engaged manner. Figure 17 The latching rounded receiving portion 186 of the actuator 184 further defines an elongated arcuate opening, which includes an engagement receiving port interface 130 of the tube holder 120. Figure 15 The extract port interface receiver 188.

[0147] The tube holder 120 also includes a latching actuation key 126 and an elongated, arc-shaped extraction port interface 130, both located within the actuator receiver 124. The extraction port interface 130 is positioned and sized to precisely fit into the extraction port interface receiver 188 when the tube holder 120 is installed to the delivery valve and the collection body 140. Similarly, the latching actuation key 126 is positioned and sized to precisely fit into the latching convex receiver 186 when the tube holder 120 is installed to the delivery valve and the collection body 140. The extraction port interface 130 also includes a concealed alcohol or other disinfectant swab 134 and a needleless extraction port 132.

[0148] Now for reference Figure 16 The figure shows a top perspective view of the delivery valve housing 142 after it has been removed from the delivery valve and the collection body 140. The delivery valve housing 142 includes a top housing 144 and a bottom housing 145. The delivery valve housing 142 also houses a valve assembly 180 and the top housing 144, as well as an elastomeric valve layer 190 located between them. The valve assembly 180 includes a valve actuator 184 and a rotary valve 182 rigidly fixed together by a shaft 181. Figure 16 (not shown in the image below) (in combination with the following) Figure 19 The valve assembly 180 will be discussed in more detail. Materials from which the housing 142, tube retainer 120, actuator 184, and valve 182 may be formed include, for example, structural polymer materials such as ABS, polyurethane, polycarbonate, PBT, PEI, PEEK, polypropylene, PET, etc. Materials from which the elastomeric layer 190 may be formed include, for example, thermoplastic urethane, thermoplastic vulcanizate, PEBA, TPE, RTV silicone, etc.

[0149] The top of the housing 144 includes an opening 146 for receiving the central axis 181 of the valve assembly passing through it, and a curved latch cantilever 147, with a latch protrusion 148 located at the distal end of the latch cantilever. The latch protrusion 148 cooperates with a latch protrusion receiving portion 186 of the valve actuator 184 to rotatably lock the valve assembly 180 relative to the housing 142 and the elastomeric valve layer 190. The top of the housing 144 also includes a needleless extraction port 154 from which, in a particular operating mode described further below, a blood collection flow 18 is provided to the tube holder 120.

[0150] Now for reference Figure 19 The accompanying drawing shows a valve assembly 180, which includes a valve actuator 184, a rotary valve 182, and a shaft 181. As discussed above, the valve actuator 184 defines a latching cam receiver 186 and a pull-out port interface receiver 188 for a pull-out port. The rotary valve 182... Figure 19The middle section is shown as defining the delivery channel 183. Valve 182 and actuator 184 are spaced apart for precise assembly on opposite sides of the housing top 144 and the elastomeric valve layer 190, as shown. Figure 22 , Figure 27 and Figure 29 As best shown, the housing top 144 is located between the actuator 184 and the elastomeric valve layer 190, the elastomeric valve layer 190 is located between the housing top 144 and the rotary valve 182, and the rotary valve 182 is located between the elastomeric valve layer 190 and the housing bottom 145. The precise dimensional setting and positioning of the various features on the valve 182, the elastomeric valve layer 190, the actuator 184, and these features on the housing top 144 are of substantial importance, as discussed above and below.

[0151] Figure 18 The following figures show a semi-transparent view of the delivery valve housing 142, including multiple fluid passages defined by portions of the housing top 144, the elastomeric valve layer 190, and the rotary valve 182. These fluid passages are selectively in fluid communication via inlet 143 with the incoming IV infusion line 10, and with the infusion lumen 160, the blood collection lumen 150, and the needleless aspiration port 154. Specifically, and referring to... Figure 21 and Figure 28 The blood collection channel 152, which has been partially described above, is further defined by the blood collection passage 194 (including the blood collection delivery port 195) and the extraction port 154. For two operating modes, namely... Figures 26-27 The infusion / non-acquisition modes shown are: Figures 28-29 In the infusion / collection mode shown, the blood collection lumen 150, passage 194, delivery port 195, and extraction port 154 are always in fluid communication. Furthermore, the infusion channel 162, which has been partially described above, is further defined by the infusion passage 197 (including the infusion delivery port 196). For both operating modes, the infusion lumen 160, passage 197, delivery port 196, inlet 143, and IV infusion line 10 are also always in fluid communication.

[0152] In contrast, selective fluid communication is provided based on the rotational position of the valve assembly 180 and the pipe retainer 120 relative to the delivery valve housing 142. Before the pipe retainer 120 is installed to the delivery valve and the acquisition body 140, the rotary valve 182 and the valve actuator 184 are in their furthest counterclockwise positions. Figure 16 and Figures 26-28 As shown in the diagram. This relative position provides an infusion / non-collection operation mode, in which the delivery channel 183 defined by the rotary valve 182 is in the rotational position 183a. Figure 27 It is best shown in the middle, but Figure 20 and Figure 26 As also shown, this provides unrestricted fluid communication between the infusion delivery port 196 and the blood collection port 195, the functions of which will be further described below.

[0153] When the tube retainer 120 is installed to the delivery valve and the collection body 140 (which includes the tube retainer 120, the valve actuator 184, and the fully available clockwise rotation of the rotary valve 182), a delivery / collection operation mode is provided, in which the delivery channel 183 is located in the rotation position 183b. Figure 21 and Figures 28-29 As shown, this provides fluid isolation between the infusion delivery port 196 and the blood collection port 195, and thus provides fluid isolation through all blood collection channels 152 and infusion channels 162. Furthermore, in infusion / collection mode, the needleless extraction port 132 is in fluid communication with the needleless extraction port 154, and therefore, in this operating mode, the blood collection channel 152 is further defined by the needleless extraction port 132 and the tube-penetrating needle 136.

[0154] The selection between infusion / non-collection mode and infusion / collection mode is provided by the installation and clockwise rotation, as well as counterclockwise rotation and disassembly of the tube retainer 120 with the delivery valve and the collection body 140 (including the associated functions of different mating structures caused by installation and rotation).

[0155] When the pipe retainer 120 is installed to the delivery valve and the acquisition body 140, the valve actuator 184 is received by the actuator receiver 124. Figure 15 In this context, the latch actuation key 126 extends downward from one side into the latch protrusion receiving portion 186, the opposite side to the side from which the protrusion 148 of the cantilever 147 extends upward into the latch protrusion receiving portion 186, thereby pressing the protrusion 148 downward and disengaging it from the latch protrusion receiving portion 186. Furthermore, when the tube retainer 120 is installed to the delivery valve and the collection body 140, the extraction port interface 130 is precisely fitted into the extraction port interface receiving portion 188. To install the tube retainer 120 to the delivery valve and the collection body 140, they are placed together, thereby assembling the fitting and retaining features as described above, and the retainer 120 is rotated so that the tube retainer retaining flap 122 engages below the retaining flange 141b.

[0156] Figure 22 A cross-sectional view of the assembled tube retainer 120, delivery valve, and collection body 140 is shown. Figure 22 Also shown is a collection tube penetration needle 136 connected to the tube holder 120, which protrudes upward to the center of the tube receiver 128 and is in fluid communication with the needleless extraction port 132. Figure 22The figure also shows the collection tube penetration needle 136 penetrating the cap 17 portion of the collection tube 15, which is axially inserted into the tube receiver 128, thus allowing blood sample 18 to be collected into the collection tube. The figure shows the assembly in normal non-blood collection mode, where the needleless extraction port 132 does not overlap with the needleless extraction port 154. In infusion / non-collection mode, the valve assembly 180 serves to supply IV fluid 14 from the IV infusion line 10 through inlet 143 to both channels 152 and 162, and thus to both lumens 150 and 160, as shown. Figure 20 As shown, the fluid continues to flow through the catheter 20 and the microtubule 210 in both channels and into the patient's vein.

[0157] In the following illustrative use of the illustrative device 110, the installation of the infusion and blood collection device 110 during intravenous treatment of a patient is described. Prior to installation of the device 110, following standard techniques well known in the art, a peripheral venous catheter 20 is typically inserted into the patient's vein and connected to the IV treatment tubing 10 via a Luer type or other connector 11. To install the infusion and blood collection device 110 in preparation for the aspiration of a clean blood sample from the patient via the catheter 20, the IV treatment fluid flow 14 through the IV infusion line 10 is stopped, and the peripheral venous catheter 20 is disconnected from the IV infusion line 10. The device's delivery valve and collection body 140 are connected to the IV infusion line 10 by connecting a connector 11 to an inlet port 143.

[0158] refer to Figures 26-27 The diagram illustrates the use of device 110 in infusion / non-collection operation mode, where the fluid flow 14 through IV infusion line 10 is subsequently restarted, and IV fluid 14 (or, for example, heparin) flowing into inlet port 143 fills both blood collection channel 152 and infusion channel 162 in housing 142, lumen 150 and 160, and passages 250 and 260 defined by catheter head body 202, until IV fluid 14 flows out from catheter head assembly 200, thereby expelling air from channels 152 and 162.

[0159] The microtubule 210 can then be inserted through the through-conduit 20 and the Luer type or other connector 204 can be fastened to the convex connector 83 (e.g., Figure 23 (As shown) Attach the catheter tip assembly 200 to the catheter 20 (catheter 20 is, for example, already held in the patient's body). Then pull the microlumen stabilizer to pull the handle 206 to remove the thread or pin from inside the microlumen 210, and as IV treatment continues, allow IV treatment fluid 14 to be infused into the patient from both the catheter 20 and the microlumen 210 (not precisely shown).

[0160] The infusion / non-collection delivery channel position 183a serves to allow IV fluid flow 14 from IV infusion line 10 to pass through both blood collection lines / channels 150 / 152 and IV infusion lines / channels 160 / 162. (Reference) Figure 20 and Figure 26 IV fluid 14 flows from IV infusion line 10 to infusion line 197. In the infusion line, the IV infusion fluid flows freely into infusion port 196 and exits through two paths: infusion line 160 and also through delivery channel 183, through blood collection port 195, into blood collection line 194, and out of blood collection line 150. Before the tube holder 120 is connected to the delivery valve and collection body 140, delivery channel 183 on valve assembly 180 is in the infusion / non-collection position 183a, and blood collection port 154 is closed to prevent fluid 14 from overflowing the port.

[0161] More specifically, and refer to Figure 30A and Figure 30B The blood collection port 154 can be sealed by the design of the elastomer central portion 155, which has slits 157 and bulges downward toward the internal pressure source of the fluid 14, wherein the internal pressure of the fluid 14 cooperates with the geometry of the central portion 155 to seal the port 154 more tightly, thereby preventing the formation of an opening 156 between the slits 157. Figure 30B and Figure 31B Alternatively or additionally, when the device 110 is in infusion / non-collection mode, the bottom surface of the valve actuator 184 against which the top surface 158 of the central portion 155 abuts can act to seal or further seal the port 154, thereby preventing the formation of an opening 156 between the slits 157. Figure 30B and Figure 31B ).

[0162] In the following illustrative use of the illustrative device 110, it is described how to draw blood 18 from a patient and into a collection tube 15 without interrupting the patient's IV treatment using the infusion and blood collection device 110. The device 110 is installed between the IV treatment infusion line 10 and the patient catheter 20, and all air is flushed out, as described above. One hand holds the tube retainer 120, which has been detached from the delivery valve and collection body 140, and pulls away the heat-sealing protrusion (not shown) that seals the blood collection port interface 130 from the tube retainer 120, thereby exposing the interface 130 (including the alcohol swab 134 and the previously sterilized collection tube tip 132).

[0163] Next, the retaining flap 122 of the tube holder 120 is aligned with the keyed opening 141a of the delivery valve and the acquisition body 140. This also aligns the extraction port interface 130 with the interface receiver 188 and the latching cam receiver 186 with the latching actuation key 126. The tube holder 120 is firmly pressed into place such that the valve actuator 184 is received in the actuator receiver 124, which presses the latching actuation key 126 into the latching cam receiver 186, thereby deflecting the latching cam 148 (including the cantilever 147) downward so that the latching cam is flush with the top surface of the housing top 144 and thus axially protrudes from the latching cam receiver 186, allowing the valve actuator 184 (including the rotary valve 182 and the elastomeric valve layer 190) to rotate. In this position, the extraction port interface 130 is also located within the interface receiving portion 188 of the valve actuator 184, thereby causing the valve actuator 184 and the rotary valve 182 to rotate when the tube holder 120 rotates clockwise relative to the housing 140.

[0164] When the latching protrusion 148 is disengaged from the latching protrusion receiving portion 186, the tube holder 120 can rotate clockwise relative to the delivery valve and the collection body 140, thereby causing the retaining wing 122 to rotate below the retaining flange 141b until the wing 122 reaches the rotation stop (not shown), thereby holding the tube holder 120 in the proper position on the delivery valve and the collection body 140.

[0165] During the clockwise rotation of the tube holder 120 relative to the delivery valve and the collection body 140, several key events occur: (1) The needleless extraction port 154 on the surface of the top 144 of the housing is drawn below the bevel 131 portion of the extraction port interface 130 and across the alcohol swab 134, thereby wiping and cleaning the needleless extraction port 154. (2) The needleless tube port 154 moves to axially align with the needleless extraction port 132, thereby cooperating to open and seal the extraction port 132, thereby allowing the collected blood 18 to flow between the needleless tube port and the needleless extraction port. (3) The delivery channel 183 on the rotary valve 182 of the valve assembly 180 is drawn from... Figures 26-27 The infusion / non-collection mode rotation position 183a (connecting the blood collection channel 152 and the IV infusion channel 162) is rotated to... Figures 28-29 The infusion / collection mode shown is rotated to position 183b, thereby isolating the blood collection channel 152 from the IV infusion channel 162.

[0166] This can be achieved by... Figure 20 and Figure 21 or Figure 26 and Figure 28 and Figure 21 and Figure 29A comparison clearly shows that the former illustrates the flow pattern of IV fluid 14 through the delivery valve and collection body 140, wherein the delivery channel 183 connects channels 152 and 162 in the non-collection rotation position 183a; the latter illustrates the flow pattern of IV fluid 14 and blood 18 through the delivery valve and collection body 140, wherein the delivery channel 183 moves to the collection position 183b, which isolates channels 152 and 162. (As in...) Figure 21 , Figure 24 and Figures 28-29 As can be seen, when the delivery channel 183 is in the blood collection position 183b, the infusion of the IV treatment fluid 14, passing through the infusion channel 162 and exiting the microtubule 210, continues uninterrupted, as shown in the image. Figure 25 As shown.

[0167] More specifically, and refer to Figure 30A and Figure 30B The blood collection port 154 can be sealed by the design of the elastomer central portion 155, which has slits 157 and bulges downward toward the internal pressure source of the fluid 14, wherein the internal pressure of the fluid 14 cooperates with the geometry of the central portion 155 to seal the port 154 more tightly, thereby preventing the formation of an opening 156 between the slits 157. Figure 30B and Figure 31B Alternatively or additionally, when the device 110 is in infusion / non-collection mode, the bottom surface of the valve actuator 184 against which the top surface 158 of the central portion 155 abuts can act to seal or further seal the port 154, thereby preventing the formation of an opening 156 between the slits 157. Figure 30B and Figure 31B ).

[0168] The next step in this illustrative use is to place the collection tube 15 into the tube receiver 128 of the tube holder 120 and press it down. Figure 22 In the position shown, the penetrating needle 136 is allowed to pierce the collection tube cap 32 and the vacuum in the tube 30 is allowed to pass through the blood collection channel 152 (i.e., through the collection tube penetrating needle 136, the needleless tube port 132, the needleless extraction port 154 sealed by the tube port 132, the passage 194, the delivery port 195, the extraction channel lumen 150, the passage 250 defined by the catheter head body 202, and the space between the catheter 20 and the microtubule 210) (as shown). Figures 24-25 and Figures 28-29 (As shown) 18 ml of blood was drawn.

[0169] refer to Figure 30B and Figure 31BIn infusion / collection mode, the blood collection port 154 is actuated by a chamfered protrusion 133a, which is defined at the distal end of the needleless extraction port 132 and is sized and shaped to cooperate in opening the blood collection port 154. More specifically, the top surface 158 of the elastomer central portion 155 is pressed axially downward by the protrusion 133a to deform the central portion 155 and allow openings 156 to be formed between slits 157, thereby allowing blood 18 to flow upward through the axial channel 133b in the port 132 and continue flowing through the penetrating needle 136 and into the collection tube 130.

[0170] Once the required volume of blood 18 has been collected into the collection tube 15, the collection tube 15 is removed from the tube receiver 128. One hand grasps the tube holder 120, and the other hand grasps the delivery valve and the collection body 140, causing the tube holder 120 to rotate counterclockwise relative to the body 140 and separate from it. This rotation and separation causes the valve actuator 182 and the rotary valve 184 to rotate to... Figure 20 and Figures 26-27 The device is rotated counterclockwise to re-engage the latching lug 148 into the latching lug receiving portion 186, thereby locking the device 110 back into the infusion / non-collection mode. In the infusion / non-collection mode, the needleless extraction port 132 is also rotated to be misaligned with the needleless extraction port 154, thereby allowing the extraction port 154 to be sealed again to prevent the formation of the opening 156. In the infusion / non-collection mode, the blood collection channel 152 and the infusion channel 162 are once again in fluid communication via the rotated position 183a of the delivery channel 182, and the IV therapy fluid 14 is once again supplied to channels 152 and 162. Figure 26 Both of these processes flush the blood collection channel 152 from which blood 18 was previously drawn, and allow the device 110 to be reused together with a new or sterilized tube holder 120 and collection tube 15.

[0171] Regarding the constraint of blood flow 18 to reduce the blood collection flow rate to a level that prevents IV fluid flow from reversing in the vein and being drawn into the blood collection tube, as with device 100, for device 110, this constraint can be achieved by an active constraint device, a passive constraint device, or a combination of active and passive constraint devices, through various methods known in the art and at different locations along the blood collection channel 152. In the above illustrative embodiment of device 110, the constraint of the flow rate is passively performed via a gauge that selects the penetrating needle 136 penetrating the end of the collection tube, thus selecting a needle with an inner diameter narrow enough to provide the required restriction on the blood flow rate. In the illustrative device 110, where the microlumen 210 extends 10 mm beyond the blood collection inlet of catheter 20, the constraint limiting the flow rate to approximately 30 ml / min allows for the provision of a desired uncontaminated collected blood sample. This desired constraint is passively provided by using a penetrating needle 136 having approximately 24 gauges. In another embodiment, it is envisioned that the required blood collection flow constraint can be achieved by using a Tesla-type valve positioned at any location along the blood collection channel 152, including a valve positioned in the housing 142.

[0172] In another embodiment, it is envisioned that the required blood collection flow constraint can be achieved by utilizing a check valve located at any position along the blood collection channel 152, in which a reverse flow rate tuned instead of a typical cut-off.

[0173] In yet another embodiment, it is envisioned that the required blood collection flow constraint can be achieved by utilizing a section of channel with a reduced diameter located at any position along the blood collection channel 152 to form the required constraint.

[0174] In yet another embodiment, it is envisioned that the required blood collection flow constraint can be achieved by reducing the gap between the outer side of the microtubule 210 and the inner side of the catheter 20.

[0175] In yet another embodiment, it is envisioned that the required blood collection flow constraint can be achieved by using a multi-lumen catheter (venous or arterial) instead of the typical peripheral venous catheter 20 and microlumen 210, but the multi-lumen catheter has an extraction channel bias and a sufficiently small diameter and length to constrain flow and prevent dilution during extraction.

[0176] In yet another embodiment, it is contemplated that the required blood collection flow constraint can be achieved by using an active device positioned at any location along the blood collection channel 152, which constrains the flow of blood 18 to the collection device. Illustratively, the active device may include a pump that draws blood and delivers it to the collection tube 15.

[0177] In yet another embodiment, it is envisioned that the required blood collection flow constraint can be achieved by having a diaphragm, needle, or other such valve positioned at any location along the blood collection channel 152 and actuated electronically or manually to form a constraint.

[0178] Another embodiment of the invention herein relates to the novel feature of using a valve to separate two or more infusion channels into a blood collection channel 152 and an intravenous therapeutic infusion channel 162, as described above. An illustrative embodiment of this feature is the use of a rotary valve as described above.

[0179] In yet another embodiment, it is envisioned that alternative valve types may be used. Illustratively, the valve may be a plug valve, a diaphragm valve, an electrically actuated solenoid valve, or a magnetically actuated valve.

[0180] In other embodiments, described herein is a rotary blood collection valve, which, as illustrated herein, has a locking feature to prevent patients (e.g., pediatric patients, emotionally agitated patients, patients suffering from different forms of dementia, or patients with other increased risks associated with additional needle insertion) from touching the blood collection port.

[0181] In yet another embodiment, a sliding blood collection valve is described herein, which has a locking feature to prevent patients (e.g., pediatric patients, emotionally agitated patients, patients suffering from different forms of dementia, or patients with an increased risk associated with additional needle insertion) from touching the blood collection port.

[0182] In another embodiment, a collection tube holder is described herein, which has an integrated alcohol wipe and means for cleaning the blood collection access port before and after aspiration by sliding or rotating the tube holder into place, as described above.

[0183] It should be understood that while the illustrative embodiments of devices 100 and 110 relate to vascular catheters (i.e., IV catheters) as contemplated herein, the different features or combinations of features disclosed herein may also be applied to other catheters, such as peripherally inserted cardiac catheters, central catheters, etc. It should be understood that, when used with a cardiac catheter, the required aspiration rate will vary depending on the geometry of the vein and the blood flow rate in that region; however, the same device 110 and system can be used to control the blood collection rate, and a suitable extension length of the microlumen tip beyond the catheter tip can be readily determined and used. Furthermore, it should be understood that features of one of devices 100 and 110 can be applied to other devices.

[0184] Figures 32-52 The illustration shows another illustrative embodiment of the infusion and blood collection apparatus, system, and / or method 300 of this disclosure. System 300 generally includes a holding component, a valve component, and an infusion component. The holding component is connected to a collection tube holder 330 for receiving a standard vacuum collection tube 315. The valve component includes a valve housing 340 (including an upper portion 340a and a lower portion 340b) that closes a movable member (e.g., a rotary valve 380). The valve component also includes an intravenous infusion (IV) inlet 343, an intravenous outlet 364, and a withdrawal port 381. The infusion component is connected to a catheter 320, such as a short peripheral IV catheter (SPIC).

[0185] Materials that can form the tube retainer 330, valve housing 340, and rotary valve 380 include, for example, medical-grade plastics and structural polymers such as ABS, polyurethane, polycarbonate, PBT, PEI, PEEK, polypropylene, PET, etc. For example, the tube retainer 330 and valve housing 340 can be formed of polycarbonate, while the rotary valve 380 can be formed of polypropylene.

[0186] At one end of the valve housing 340, the IV inlet 343 includes a separate or integrally formed convex connector (not shown) for fluid connection with a concave connector 311. At the other end of the valve housing 340, a catheter tip 363 is connected to the valve housing 340 via a Luer lock 365 for fluid connection of the IV infusion channel 358 and the IV infusion / blood collection channel 354 to the catheter 320. The Luer lock 365 engages the outer surface (outer edge) of the housing 340 adjacent to the outlet 364.

[0187] The catheter tip 363 may have an intravenous infusion microtubule 360 ​​inserted therein or passing through it, the intravenous infusion microtubule 360 ​​being fluidly connected to an infusion tube 357 located within an IV infusion channel 358 positioned in the valve housing 340. In some embodiments, the infusion tube 357 is not required because its absence also achieves sufficient connection and sealing of components to form a hermetically sealed channel 358. By connecting to the valve housing 340, the catheter tip is simultaneously connected to a hemotube 353 located within at least a portion of the IV infusion / blood collection channel 354, wherein the outlet 364 of the channel 354 is fluidly connected to the catheter 320, such as... Figure 48 As shown. In some embodiments, the blood tube 353 is not required because its absence also achieves full connection and sealing of the components to form a sealed channel 354. In some embodiments, the microlumen 360 may include a coated tip 361, for example, coated with PTFE to reduce friction when the catheter 320 is inserted into the microlumen 360.

[0188] Rotary valve 380 includes valve member 382 defining valve passage 389, which has an opening on a side of valve member 382 (see...). Figures 45-49 Valve component 382 further defines extraction port 381 (see...). Figure 33 The extraction port is fluidly blocked and held by the septum 376 and the receiving section 606a / b, through which the engagement features 336a and 336b of the receiving tube holder 330 pass, which will be further described below.

[0189] The tube holder 330 includes an extraction needle 334 and an elastomeric needle cap 335. The extraction needle 334 is positioned to pierce the needle cap 335 and septum 376 of the infusion and blood collection system 300, as well as a vacuum collection tube 315 housed within the tube holder 330, during use. When not in use, the tube holder may include a connectable cap 370 to prevent injury to the user from exposure of the extraction needle 334. For efficiency purposes, Figure 33 The needle cap 335 shown is not shown in the rest of the figures.

[0190] refer to Figure 33 and Figure 48 An IV infusion / blood collection channel 354 (which may be defined by a portion of the blood tubing 353, a portion of the catheter 320, or both) and an IV infusion channel 358 (which may be defined by a portion of the infusion tubing 357, a portion of the microlumen 360, or both) extend between the IV inlet 343 and outlet 362 of the valve housing 340. When the catheter tip 363 is connected to the outlet 364 using a Luer lock 365, the microlumen 360 is coaxially inserted into the interior of the catheter 320. For reasons described in more detail below, the relative lengths of the catheter 320 and the microlumen 360 are such that the distal end 362 of the microlumen 360 extends from the distal end 322 of the catheter 320 and extends distally beyond the distal end of the catheter, thus extending further axially along and within the patient's vein.

[0191] The microtubule 360 ​​is in fluid communication with the infusion channel 358. The radial space between the outer surface of the microtubule 360 ​​and the inner surface of the catheter 320 is in fluid communication with the blood collection channel 354 via the outlet 364 (see [link]). Figure 33 and Figure 48It has been found that a microlumen 360 having at least a minimum amount of rigidity while maintaining sufficient flexibility to be safely held within the catheter 320 and the vein is advantageous for inserting the microlumen 360 into the catheter 320. For example, reinforced microlumens formed of uncoated (or coated) polyimide and braided (or unbraided) layers (e.g., formed of stainless steel) (such as product code 165-111 (with an ID of 0.0165 inches) available from Microlumen of Oldsmar, FL) have been found to have acceptable properties.

[0192] refer to Figure 34 The tube holder 330 includes a central tube receiver 332, a tube stop 333 at the base of the receiver 332, tube holder engagement features 336a and 336b, and an extraction needle 334. (As follows) Figure 33 , Figure 35 and Figure 37 As shown, tube retainer engagement features 336a and 336b (e.g., protrusions extending downward from the tube retainer 330 and having angled surfaces and locking engagement features defined on those surfaces) are configured to fit within the receiving portions 346a and 346b in the valve housing 340 and engage with the bevels 348a and 348b defined by the valve housing 340 when the tube retainer 330 is coupled to the valve housing 340. During engagement of the tube retainer 330 with the valve housing 340, the extraction needle 334 extends axially into the septum top 375 and the sample chamber 377, inserting the needle channel 384 into the valve internal passage 389 (see...). Figures 34-37 and Figures 47-49 In the illustrated embodiment, the entire tip of the needle 334 extends into the sample chamber 377, and all angled surfaces of the tip of the needle 334 are located within the sample chamber 377, such as... Figure 36 and Figure 37 As shown.

[0193] Tube retainer interfaces 336a and 336b engage with extraction needle 334 to connect blood collection tube 315 to valve housing 340. Tube retainer 330 also serves to position rotary valve 380 in non-collection position 383a (see...). Figure 48 ) and collection location 383b (see Figure 49 The needle 334 rotates between the receiving portions 346a and 346b, and in the embodiment shown, it rotates approximately 15 degrees relative to the valve housing 340. The needle 334 extends through the septum 376 located in the extraction port 381 of the rotary valve 380, as the engaging features 336a and 336b slide through the receiving portions 346a and 346b and the tube retainer 330 is axially connected to the valve housing 340.

[0194] Rotation of the rotary valve 380 is provided by the continuous downward movement of engagement features 336a and 336b through receiving portions 346a and 346b to contact inclined surfaces 348a and 348b, as the tube retainer 340 is manually extended axially downward and guided to rotate relative to the valve housing 340. This continuous downward axial movement contacts the opposing inclined surfaces of inclined surfaces 348a and engagement features 336a, and the opposing inclined surfaces of inclined surfaces 348b and engagement features 336b, respectively, guiding the rotation of engagement features 336a and 336b and causing the rotary valve member 382 to rotate relative to the valve housing 340 via the receiving portions 346a and 346b defined therein. Corresponding locking surfaces of engagement features 336a and 336b, corresponding to locking surfaces of the valve housing 340, restrict downward movement toward the tube retainer 330 and hold the tube retainer 330 in the proper position relative to the valve housing 340, thereby also holding the rotary valve 380 in the proper position relative to the valve housing 340.

[0195] Relative to the tube holder 330, the extraction needle 334 extends through the tube stop 333 and has a tip 334a that extends above the tube stop 333 and upwards into the tube receiver 332, or, if the blood collection tube is connected, directly through the needle cap 335 into the blood collection tube 315. The extraction needle 334 also extends downwards below the tube stop 333 and has a bottom end 334b ​​that extends below the tube stop 333 and in the central region 339 between the extraction port interfaces 336a and 336b. Figure 35 Extending downwards within. Optionally, mechanical features may be provided for the tube retainer 330, housing 340, and / or rotary valve 380, thereby providing mechanical protrusions that engage with corresponding braking devices or other sensing feedback to indicate the limits of full rotation and / or axial translation to ensure proper use and operation.

[0196] Figures 34-37 The series illustrates the stages of blood sample collection: preparation system 300 for blood extraction ( Figures 34-35 ), and when the system 300 is in the infusion / collection configuration, blood is drawn into one or more collection tubes 315 in the infusion / collection operation mode 383b. Figures 36-37 ).

[0197] refer to Figures 34-35 Before the tube retainer 330 is connected to the valve housing 340, the rotary valve 380 is positioned in the non-collection position 383a (see [link]). Figure 48 In this position, the valve passage 389 of the rotary valve 380 fluidly connects the IV inlet 343 of the valve housing 340 to the blood collection channel 354 of the valve housing 340, thereby allowing the device to supply IV fluid 314 to the catheter tip 363 and the catheter 320.

[0198] refer to Figure 36 , Figure 37 and Figures 45-49 When the rotary valve 380 is rotated to the sampling position 383b (see...) Figure 49 When, for example, by inserting the engagement features 336a and 336b and the extraction needle 334 into the valve housing 340 and the septum 376 respectively, the valve passage 389 of the rotary valve 380 is moved so that it is not aligned with the IV inlet 343, becoming fluidly isolated from the infusion passage portion 358 (fluidly isolated from the device 300) but still in fluid communication with the blood collection passage 354 (fluid communication with the device 300), thereby providing a path for blood 318 entering the distal end 322 of the catheter 320 to pass through the blood tube 353 and be supplied to the valve passage 389, the sample chamber 377 of the septum 376, and the needle passage 384. In this collection position 383b, the sample chamber 377 of the septum 376 (which is positioned within the extraction port 381) is fluidly connected to the collection tube 315 through the needle passage 384.

[0199] When two locations are described as "fluid isolated," "fluid connected," or "fluid interconnected," as described in the paragraphs above, it can be understood that a fluid path outside the device 300 can exist between the two locations. For example, when the rotary valve 380 is rotated to... Figure 49 When the sampling location 383b shown causes the IV inlet 343 to be fluidly isolated from the valve passage 389, this fluid isolation occurs within the device 300, and indeed there is a fluid path from the inlet 343 via the infusion passage 358, the blood vessel and blood sampling passage 354 to the valve passage 389. When such a fluid path exists outside the device / system, terms such as "fluid isolation," "fluid connection," and "fluid connectivity" in this context are intended to imply that the isolation, connection, or connectivity relates to the internal pathways and functions of the device / system 300 or 100.

[0200] Once blood has been collected, the collection tube 315 can be disconnected from the tube holder 330, and subsequent collection tubes 315 can be connected, filled, and disconnected if needed. Blood 3 will not flow through the needle 334 due to the absence of the collection tube 315, the lack of vacuum, the passive fluid flow constraint provided by the needle 334, and the additional seal provided by the elastomeric cap 335 covering the upper end 334a of the needle 334. Appropriate flow constraint can be provided by selecting the correct ID of the needle 334, by clamping the needle 334 to a specific desired cross-sectional area, or by other mechanical passive means for restricting flow.

[0201] In order for system 300 to return to the infusion / non-acquisition configuration and infusion / non-acquisition operation mode 383a (see...) Figures 34-35The tube retainer 330 is rotated counterclockwise and axially separated from the valve housing 340. Rotating the tube retainer 330 counterclockwise returns the rotary valve 380 to the non-collection valve position 383a, fluidly reconnecting the blood collection channel 354 to the therapeutic fluid 314 from the IV inlet 343. Rotating the tube retainer 330 counterclockwise also axially and upwardly translates the interfaces 336a and 336b and the needle 334. Advantageously, the septum 376 is self-sealing and reusable, so that when the needle 334 is repeatedly removed, the IV fluid 314 flows through the valve passage 389 without leakage through the septum 376.

[0202] Advantageously, the collection of blood 318 occurs simultaneously without interrupting the IV therapy fluid 314 as it passes through the infusion channel 358, exits at the distal end 362 of the microtubule 360, and enters the patient's vein for infusion. The ability of system 300 to provide this function is partly attributed to two features of the device: the tip of the microtubule 360 ​​extends into the vein beyond the optimal minimum distance of the tip of catheter 320 (see [link to relevant documentation]). Figure 32 ), and related constraints on the flow of blood 318 being collected when the rotary valve 380 is rotated to the collection position 383b.

[0203] When determining the precise dimensions of components in the infusion and blood collection device, system, and / or method 300 (or device / system / method 100), numerous parameters can be considered to ensure that the device / system will operate effectively under various conditions. These parameters include the patient type (e.g., human (including adults, adolescents, children, and infants), canines, felines, etc.), the location of the vein (arm, leg, etc.), the typical diameter of the vein being touched, the standard apparent velocity of venous blood in the touched vein, the expected density and viscosity of the IV fluid, the standard blood density and viscosity, the thickness of the microtubule wall, and the standard vacuum pressure in the blood collection device.

[0204] In one exemplary embodiment, the distal tip 362 of the microtubule 360 ​​extends at least 9 mm (0.35 inches) beyond the distal tip 322 of the catheter 320, the needle 334 has an inner diameter of 0.30 mm (0.012 inches), and a length of 3.3 cm (1.3 inches). This results in a maximum blood collection flow rate of 5 ml / min and prevents the IV fluid 314 flowing from the distal tip 362 of the microtubule 360 ​​from mixing with the blood 318 drawn into the distal tip 322 of the catheter 320 (collected in the collection tube 315). Devices / systems / methods with these characteristics are effective for use with typical veins in the adult forearm, wherein typical veins have standard forearm venous blood apparent velocity, typical forearm vein diameter, IV flow rate greater than 1 ml / min, minimum microtubule wall thickness, standard blood density and viscosity, typical IV fluid density and viscosity, and values ​​from current vacuum products (e.g., and The standard vacuum pressure (mmHg).

[0205] In another embodiment, the distal tip 362 of the microtubule 360 ​​extends at least 3 mm (0.12 inches) beyond the distal tip 322 of the catheter 320, and the inner diameter and length of the needle 334 are set to allow a maximum blood collection flow rate of less than 5 ml / min to prevent IV fluid 314 from mixing with blood 318 collected through the catheter 320.

[0206] Additional implementations include microtubule lengths and needle sizes configured to draw blood from patients and veins of different sizes (such as the arms or legs of adult, pediatric, or neonatal patients) without causing IV fluid contamination. For example, a manufacturer could sell three sizes of the device / system: one for adult patients, one for pediatric patients, and one for neonatal patients.

[0207] and Figure 1 and Figure 32 The overall design of the implementation methods described herein, similar to those of other implementation methods, allows the device / system / method to be easily adapted for effective operation in different scenarios. For example, by adjusting three features—the distance by which the distal tip 362 of the microtubule 360 ​​extends beyond the distal tip 322 of the catheter 320, the diameter of the lumen passing through the needle 334, and the length of the lumen passing through the needle 334 (which can be approximated to the length of the needle 334)—the device / system / method can be modified for different patients and different situations, allowing for the aspiration of blood not mixed with the IV fluid while infusing IV fluid.

[0208] Depending on the size of the catheter 320 used, the microlumen 360 may occupy between 5% and 95% of the inner diameter of the catheter 320. In other embodiments, the microlumen 360 occupies between 10% and 50% of the inner diameter of the catheter 320, and in yet another embodiment, the microlumen 360 occupies between 15% and 30% of the inner diameter of the catheter 320.

[0209] The microlumen 360 must be large enough that when the device switches from infusing IV fluid through both the microlumen 360 and the catheter 320 to infusing IV fluid only through the microlumen 360 (catheter 320 is used for blood aspiration), the passage through the microlumen 360 cannot generate a back pressure in the IV fluid exceeding the IV pump's set back pressure for detecting occlusion (e.g., greater than 10 psi). If the pressure in the microlumen 360 becomes too high when only the microlumen 360 is infusing IV fluid, the IV pump will reach its preset occlusion pressure (essentially detecting the presence of occlusion) and automatically shut off (essentially "assuming" the presence of occlusion), thereby stopping IV fluid infusion into the patient and inhibiting blood from gushing out of the catheter 320 when the healthcare provider stops collecting blood from the patient.

[0210] In illustrative embodiment 300, catheter 320 is an 18-gauge catheter, although other embodiments may include larger gauge catheters (e.g., 16-gauge, 14-gauge, and 12-gauge catheters) without significantly altering (more than 20 percent (20%)) the size of other parts of device 300. Smaller catheters (e.g., 24-gauge and 26-gauge catheters) may also be used in device 300 to accommodate smaller patients (e.g., preterm infants), although other parts of device 300 may require resizing.

[0211] In terms of restricting the blood flow 318 to reduce the blood collection flow rate to the extent that the IV fluid flow does not reverse in the vein and is drawn into the catheter 320 and the blood collection tube 315, such restriction can be achieved at different locations along the flow path of blood 318 between the distal end 322 of the catheter 320 and the blood collection tube 315 by an active restriction device (e.g., a constructible valve, worm gear, or pump), a passive restriction device, or a combination of active and passive restriction devices.

[0212] In the above illustrative embodiment of system 300, passive flow rate constraint is achieved by selecting a gauge for the extraction needle 334 penetrating the end of the collection tube 315. A needle with a sufficiently narrow inner diameter is selected to provide the required restriction on blood flow rate. If a larger inner diameter is used, it is necessary to reduce the vacuum in the blood collection tube 315 (differently described as a smaller negative pressure, a weaker vacuum, or a higher absolute pressure), increase the needle length (the slowing of the fluid is a function of the surface area inside the needle), or a combination of both. The advantage is achieved by using the entire length of the needle to slow the flow of the extracted blood to an appropriate rate. While some embodiments may constrain the flow rate using necking or clamping methods (which create a small hole along a short distance in the flow direction), care must be taken because this type of flow constraint increases the possibility of negative effects, such as damage to the blood sample (e.g., hemolysis caused by blood shearing or other physical forces).

[0213] In the illustrative apparatus / system / method 300, the distal end 362 of the microtubule 360 ​​extends, for example, about 10 mm beyond the distal end 322 of the catheter 320, to constrain the flow rate to about 5 ml / min or less, providing the desired uncontaminated blood sample. This desired constraint is provided by using an extraction needle 334 with about 24 gauges.

[0214] The volumetric flow rate (Q) of blood 318 is driven by the pressure change (ΔP) of the blood 318 between the patient and the collection tube 315, and most significantly at the point of highest passive constraint in the blood flow 318, i.e., at the extraction needle 334, in the illustrative embodiment of system 300. To specify the needle gauge that will limit the volumetric flow rate (Q) to a desired value, such as approximately 30 ml / min or less, or approximately 15 ml / min or less, or 10 ml / min or less, fluid dynamics principles for fluid flow (with applied forces and no-slip boundary conditions) can be used between the desired blood volumetric flow rate (Q) and the pressure gradient (ΔP). In the illustrative embodiment, for example, using a 1.16-inch 18-gauge catheter and a 6 ml red collection tube 315, a typical flow rate of blood 318 of approximately 7 ml / min is observed.

[0215] Figures 38-40The illustration depicts an example of an extraction needle 334 for positioning within a tube holder 330 of a system 300, according to one embodiment of the present disclosure. The illustrative extraction needle 334 may have a body 400 cut from a section of stainless steel injection tubing material and may include frontal ends 385a and 385b. In the illustrated embodiment, front end 385a serves as a puncture cap sleeve 335 and a collection tube 315, while front end 385b serves as a septum 376 for puncturing the system 300. The extraction needle 334 may have an overall length 402 of approximately 1.3 inches, including, for example, a first portion 404 of approximately 0.28 inches in length extending into a central region 339 of the tube holder 330, a second portion 406 of approximately 0.20 inches in length attaching the needle 334 to the tube holder 330 (e.g., using adhesive), and a third portion of approximately 0.85 inches in length, its front end extending into a central tube receiver 332. Each end portion 385a and 385b includes a beveled portion and a lancet portion. The front end portion 385a is configured to penetrate the seal of the vacuum container 315 and includes a beveled portion 422 and a secondary beveled portion 424. The beveled portion 422 has a primary bevel angle 412 of approximately 11 degrees relative to the body 400, and the secondary beveled portion 424 has a secondary bevel angle 416 of approximately 19 degrees relative to the longitudinal axis of the body 400. The front end portion 385b is configured to penetrate the septum 376 and includes a beveled portion 418 and a secondary beveled portion 420. The beveled portion 418 has a primary bevel angle 410 of approximately 18 degrees relative to the longitudinal (long) axis of the body 400, and the secondary beveled portion 420 has a secondary bevel angle 414 of approximately 32 degrees relative to the longitudinal axis of the body 400. To achieve the optimal flow rate as described above, the needle 334 may include an inner diameter 426 of approximately 0.012 inches (0.3 mm) and an outer diameter 428 of approximately 0.036 inches.

[0216] As described herein, in acquisition mode 383b, when the tube holder 330 is connected to the rotary valve 380, the extraction needle 334 punctures the septum 376, and the septum 376 self-seales upon disengagement of the tube holder 330 and the rotary valve 380. To achieve this self-sealing function, the septum 376 can be constructed using an elastomeric material. The septum 376 generally has a roughly truncated conical shape, comprising a cylindrical body 500, a planar inlet surface 375 for the entry of the extraction needle 334, and a planar outlet surface 502 for the exit of the extraction needle 334 from the septum 376 and into the sample chamber 377 (see [link to documentation]). Figures 36-37 The septum 376 is installed on the rotary valve 380, and the planar surface 504 is positioned facing the IV infusion / blood collection channel 354. The puncture surface 375 is planar and can be easily cleaned by simple wiping once collection has been performed and the tube retainer 330 has been removed.

[0217] The transition surface 506 and the puncture exit surface 502 together define the upper boundary or dome of the internal sample chamber 377. Advantageously, once collection is made through the extraction needle 334 within the sample chamber 377 and the extraction needle 334 is removed from the sample chamber 377, the septum 376 facilitates flushing any residual fluid (e.g., blood) remaining in the sample chamber 377 into the IV infusion / collection channel 354 once the IV fluid 314 flows back through the channel 354 when the rotary valve 380 is rotated to the non-collection position 383a. In other words, the shape of the bottom of the septum 376 can be configured such that the IV fluid 314 flushes away any residual fluid (such as fluid adhering to the wall of the sample chamber 377) remaining in the sample chamber 377 after collection from the second end of the body (the end defining the sample chamber 377) and enters the IV infusion / blood collection path 354 after the rotary valve 380 is switched from the collection position 383b to the non-collection position 383a. To facilitate flushing of the sample chamber 377, in some embodiments, the sample chamber 377 may extend to less than half the full length of the septum 376. Providing the sample chamber 377 for needle 334 insertion into the septum 376 is advantageous because the concave sample chamber 377 allows for a narrower IV infusion / collection channel 354 (i.e., a smaller cross-sectional diameter), and the smaller cross-sectional area can result in easier flushing. While the curved surface of the sample chamber 377 will also receive the needle 334 and facilitate flushing, the truncated conical shape described herein provides a combination of space for the needle 334 and flushing capability.

[0218] In alternative embodiments, the diaphragm 376 and the rotary valve 380 together form a continuous single-piece article. In these embodiments, the sample chamber 377 is similarly a raised portion of the valve passage 389 formed by the rotary valve 380.

[0219] To facilitate the aforementioned collection and rinsing operations, at least one embodiment of the sample chamber 377 has the following approximate dimensions: a diameter 508 of 5.08 mm on the top surface 375; a height 510 of 4.8 mm; a diameter 512 of 4.76 mm on the bottom surface 504; a diameter 514 of 2.54 mm at the opening of the sample chamber 377; a diameter 516 of 1.0 mm at the puncture exit surface 504 in the sample chamber 377; a depth 518 of 1.91 mm; a surface angle 520 of 92 degrees relative to the normal of the top surface 375 on the body surface 500 between the top surface 375 and the bottom surface 504; and a surface angle 522 of 67.5 degrees relative to the normal of the puncture surface 502 on the sample chamber transition surface 506. For example, in one embodiment, the surface angle 522 is less than about 70 degrees, the ratio of diameter 514 to diameter 516 is greater than about 2.5, and the ratio of depth 518 to diameter 514 is less than about 1.0 or less than about 0.75.

[0220] The sample chamber 377 is advantageously shaped and sized to accommodate the entire edge of the extraction needle (e.g., the beveled portion 418 of the extraction needle 334), allowing acquisition to proceed unimpeded by any surface of the septum 376. The sample chamber 377 is also advantageously shaped and sized to have a transition surface 506 that is inclined (non-perpendicular) relative to the normal of the puncture surface 502. This transition surface provides resistance and thereby prevents the sample chamber 377 from inverting when the extraction needle 334 punctures the surface for one or more acquisitions. In alternative embodiments of the sample chamber 377, the shape of the chamber 377 may be set as a circular dome instead of a truncated cone. However, in some cases, the circular dome may invert upon insertion of the extraction needle 334, thereby blocking the gap of the needle 334 and hindering acquisition.

[0221] Furthermore, providing a concave lower surface (e.g., surfaces 502, 504, and 506) for the extraction needle 334 allows the IV infusion / collection channel 354 to be smaller than an embodiment without a concave lower surface, resulting in a smaller sample chamber and faster flushing away of residual body fluids by IV fluid.

[0222] In some embodiments, sample chamber 377 defines a central axis (such as an axis extending vertically from outlet surface 502) that is perpendicular to the general direction of fluid flow through valve passage 389, which is generally parallel to the lumen in blood tube 353.

[0223] Now for reference Figures 45-49 These figures illustrate a rotary valve 380 according to one embodiment of the present disclosure. In use, the rotary valve 380 is inserted into a valve housing 340, with the outer edge 608 and the upper valve portion 340a (see figure 1). Figure 33 A flush surface is formed. An opening 602 in the rotary valve 380 defines an inlet passage into the valve passage 389, which connects the IV inlet 343 to the IV inlet / collection passage 354 defined by the valve housing 340 when the device is in IV infusion / non-collection mode 383a. More specifically, refer to... Figure 48In IV infusion / non-collection mode 383a, IV fluid 314 enters the port opening 602 and flows directly through the rotary valve 380 before exiting through the slit 604, into the blood collection channel 354, and flows toward the catheter 320. Once the tube holder 330 and the associated vacuum collection tube 315 are inserted into the rotary valve 380, specifically by pressing the inclined tube holder 330 engagement features 336a and 336b into the rotary valve receivers 606a and 606b, both the tube holder 330 and the rotary valve 380 rotate, from the non-collection valve position 383a to the collection valve position 383b. In the non-collection valve position, the valve passage 389 is fluidly connected to both the IV inlet 343 and the blood collection channel 354 (see [link to original text]). Figure 48 In the collection valve position, valve passage 389 is fluidly isolated from IV inlet 343, but remains fluidly connected to blood collection channel 354 (see...). Figure 49 ).like Figure 45 As shown, the seal 603 may surround the port opening 602 to prevent fluid leakage into the space between the valve member 382 and the valve housing 340. For example, the seal 603 may be defined on the surface of the valve member 382, ​​for example, by a medical-grade silicone surface layer or other seals, gaskets, or rings.

[0224] With the collection valve in position 383b and the vacuum collection tube installed in the tube holder 330, blood 318 flows through the port slit 604 into the rotary valve 380 and eventually into the collection tube 315 (see...). Figures 36-37 Valve passage 389 forms part of an infusion / non-collection passage and a blood collection passage, respectively, in valve positions 383a and 383b. Advantageously, slit 604 is elongated, so that when the valve is rotated from infusion / non-collection valve position 383a (… Figure 48 Rotate approximately 15 degrees to position 383b of the infusion / collection valve. Figure 49 When this occurs, a fluid connection is maintained between valve passage 389 and infusion / blood collection channel 354, while valve passage 389 is disconnected from IV inlet 343. For example... Figure 46 As shown, seal 605 may surround port slit 604 to prevent fluid leakage into the space between valve member 382 and valve housing 340. For example, seal 603 may be defined on the surface of valve member 382, ​​for example, by a medical-grade silicone surface layer or other seals, gaskets or rings.

[0225] Figure 48 and Figure 51 A microtubule 360 ​​positioned within an IV infusion channel 358 is depicted. For illustrative purposes, the microtubule 360 ​​is not shown in [the image / image / description]. Figure 49 , Figure 50 and Figure 52Depicted in [reference]. In one embodiment, the microtubule 360 ​​and the infusion tube 357 are engaged to the valve housing 340 by initially placing approximately 1-3 mm of the tip of the microtubule 360 ​​within the infusion tube 357. (Reference) Figure 33 As depicted in the diagram, the left end of the microtubule 360 ​​is initially positioned within the right end of the infusion tube 357. Adhesive is applied to the outer surfaces of the joined microtubule 360 ​​and infusion tube 357, and the joined microtubule 360 ​​and infusion tube 357 are inserted into the IV infusion channel 358. Upon hardening, the adhesive holds the microtubule 360 ​​and infusion tube 357 together, retaining them within the IV infusion channel 358 and helping to seal any open spaces between the microtubule 360 ​​and infusion tube 357 that fluid might otherwise flow through.

[0226] Figures 50-51 The figure depicts a cross-sectional view of the connection between the valve housing 340 (which includes an infusion / blood collection channel 354 and an IV infusion channel 358), the Luer lock 365, the catheter tip 363, and the catheter 320. Figure 52 The figure depicts an end view of a valve housing 340, which is connected to a conduit 320 via a conduit head 363, but the conduit head 363, the conduit 320, and the microlumen 360 are removed from the view. Figure 52 The end view shows IV outlet 364, including a first opening 702 leading to IV infusion channel 358 that typically accommodates microtubule 360 ​​and a second opening 704 leading to infusion / blood collection channel 354.

[0227] More specifically, the valve housing 340 includes an IV outlet 364 that forms an outwardly extending receiver and has a distal end defining a distal surface 706, wherein the distal surface 706 is a generally concave surface that may include both curved and non-curved portions. The illustrated embodiment includes a first portion 708 and a second portion 710, which are combined into a similar asymmetrical funnel shape, for example, its "funnel opening" portion being centered on and formed by an infusion / blood collection channel 354, and an IV infusion channel 358 extending through a funnel-shaped wall opening. The first portion 708 defines a curved cross-sectional surface, wherein the infusion / blood collection channel 354 extends through the valve housing 340 and terminates on the surface of the first portion 708. The second portion 710 defines a concave, convex, or planar cross-sectional surface, wherein the infusion channel (receiving the microtubule 360) extends through the valve housing 340 and terminates on the surface of the second portion 710.

[0228] When operating in infusion / non-collection mode 383a, IV fluid flows to the patient via two pathways: through IV infusion channel 358 to microlumen 360, and through blood tubing 353 to catheter 320. Upon switching to infusion / collection mode 383b and with aspiration applied to infusion / blood collection channel 354, IV fluid continues to flow to the patient through IV infusion channel 358 and microlumen 360, while blood tubing 353 and catheter 320 deliver bodily fluids (e.g., blood) from the patient. When switching back to infusion / non-collection mode 383a, IV fluid continues to flow to the patient through IV infusion channel 358 and microlumen 360, and IV fluid begins to flow through infusion / blood collection channel 354, blood tubing 353, and catheter 320, moving bodily fluids from infusion / blood collection channel 354, sample chamber 377, blood tubing 353, and catheter 320 into the patient's body. As can be understood from this description of the self-flushing nature of System 300, healthcare professionals caring for patients do not need to flush System 300 after aspiration of bodily fluids.

[0229] The shape and height of the recessed dome of the sample chamber 377 affect the effectiveness of the flushing fluid (e.g., IV fluid) in removing residual fluid (e.g., blood) remaining in the sample chamber. Higher domes tend to be less effective in removing residual fluid, especially at low flow rates. However, a dome that is too short or too small will not provide sufficient clearance for the extraction needle 334 to enter the sample chamber.

[0230] Due to the shape of the sample chamber 377 of the septum 376, IV fluid will move to all corners of the sample chamber 377 and self-flushing away all residual body fluid. Although the exact mechanism is not clear, it is believed that the sample chamber 377 of the septum 376 generates eddies (and / or turbulence) in the fluid flowing through the valve passage 389 when it reaches the sample chamber 377, causing the fluid to circulate at an increased velocity near the surface 506 of the sample chamber 377, generating sufficient friction with the surface to rapidly flush all body fluid into the valve passage 389 and back into the patient.

[0231] Because the fluid appears to lose its ability to be effectively removed from the passage as it moves from the sample chamber 377 and approaches the distal end 705 of the valve housing 340 (e.g., the fluid may lose much of its turbulence), the distal end 705 of the valve housing 340 is carefully shaped to effectively remove (e.g., flush) all remaining fluid in the chamber between the end of the infusion / blood collection channel 354 and the initiation of the catheter 320 into the patient. Figures 48-52In the illustrated embodiment, the distal end 705 of the IV outlet 364 of the valve housing 340 defines an asymmetrical shape as shown, such as surface 706. The asymmetrical shape of surface 706 resembles a truncated cone, which has a first portion 708 approximately centered on the opening of the infusion / blood collection channel 354 (due to its position in...). Figure 50 The orientation in the middle, which can be called the upper part) and the second part 710 (due to its position in Figure 50 The asymmetrical portions (which may be referred to as the lower portions) are defined individually because their shapes may differ. In some embodiments, the asymmetrical shape resembles the surface of an oblique cone. This asymmetrical shape causes IV fluid 314 flowing through the connection region 703 to completely and rapidly flush out all residual body fluid in the connection region 703 through the conduit 320. Although the exact mechanism is unknown, the asymmetrical funnel shape of the concave surface 706 appears to generate eddies (and / or turbulence) in locations where this causes sufficient movement of fluid near the surface of the concave surface 706 to rapidly flush body fluid away from the surface 706 and back into the patient.

[0232] exist Figures 48-50 In the illustrated embodiment, the vertex of surface 706 (where the curved surfaces of the concave surface 706 would converge if not for the gap created by the infusion / blood collection channel 354) is recessed behind the opening of the infusion / blood collection channel 354. In other words, the vertex may be located inside the infusion / blood collection channel 354. In some embodiments, the vertex is biased to one side of the central axis 355 of the infusion / blood collection channel 354 (in... Figure 50 In this configuration, the apex is biased "above" the central axis and toward the outer edge of the valve housing 340 adjacent to the outlet 364, in other words, toward the outer edge of the portion of the valve housing 340 connected to the Luer lock 365. In these embodiments, the maximum depth of the concave surface is biased to one side of the central axis 355.

[0233] The central axis 709 of the concave surface 706 originates at the apex of the infusion / blood collection channel 354 and is inclined at an angle 707 relative to the central axis 709 of the channel 354 (or relative to the longitudinal axis of the valve housing 340). In some embodiments, the angle 707 is 10 to 30 degrees, and the angle between the axis 709 and the surface of the concave surface 706 is 15 to 40 degrees; in other words, the total included angle of the cone is about 30 to 80 degrees. In other embodiments, the angle 707 is 15 to 25 degrees, and the angle between the axis 709 and the surface of the concave surface 706 is 20 to 25 degrees; in other words, the total included angle of the cone is about 40 to 50 degrees. In yet another embodiment, the angle 707 is about 20 degrees, and the angle between the axis 709 and the surface of the concave surface 706 is about 23 degrees; in other words, the total included angle of the cone is about 45 degrees.

[0234] Although at least one shape of the concave surface 706 has been described as an approximate cone with a vertex, which could mean that the sides of the cone converge at a single point, in other embodiments the shape is generally similar to a cone, but the surface does not converge at a single point, but rather converges to define a line that can be straight (one-dimensional) or curved (two-dimensional or three-dimensional). Furthermore, while the cross-section of the concave surface 706 is generally depicted as a straight line, which is advantageous in manufacturing the device, in other embodiments the cross-section of the concave surface 706 is curved. In yet another embodiment, the concave surface 706 has a tapered cross-section, which has manufacturing advantages at least in part due to its relatively simple shape.

[0235] The IV infusion channel 358 intersects the concave end surface 706 at a location different from where the infusion / blood collection channel 354 intersects with the end surface 706. In some embodiments, the location and apex of the intersection of the IV infusion channel 358 and the concave end surface 706 are located on the opposite side of the central axis 355 of the infusion / blood collection channel 354. Since the microlumen 360 extends through the IV infusion channel 358 and into the catheter 320, fluid that does not enter or leave the infusion / blood collection channel 354 mixes with the fluid in the microlumen 360.

[0236] As described above, the claimed embodiment of system 300 can quickly and effectively flush out any residual blood that may remain in the catheter 320, the infusion / blood collection channel 354, or the connection area 703 between the catheter 320 and the valve housing 340. Once system 300 switches from IV infusion / collection mode 383b back to IV infusion / non-collection mode 383a, blood drawn from the patient is returned to the patient via catheter 320. In the illustrative embodiment, after switching from IV infusion / collection mode, a minimum IV infusion rate of 10 ml / h adequately and promptly flushes system 300 to prevent residual blood from remaining in the device, including the area within the connection area 703 that is partially obstructed by the microlumen 360.

[0237] Embodiments of this disclosure include infusion and blood collection devices, systems, or methods that include IV infusion lines, IV catheters, or both IV infusion lines and IV catheters, while other embodiments include infusion and blood collection devices or systems that are independent of IV infusion lines and IV catheters.

[0238] The frames of reference that may be used herein can generally relate to various directions (e.g., up, down, forward, and backward), which are provided only to help the reader understand the various embodiments of this disclosure and should not be construed as limiting. Other frames of reference may be used to describe various embodiments, such as specifying the direction of motion of the projectile as it leaves the launcher as up, down, backward, or any other direction.

[0239] Although examples, one or more representative embodiments, and specific forms of this disclosure have been detailed and described in the accompanying drawings and foregoing description, they should be considered illustrative rather than restrictive or limiting. Description of a particular feature in one embodiment does not necessarily mean that those particular features are limited to that one embodiment. As will be understood by those skilled in the art, some or all features of one embodiment may be used in combination with some or all features of other embodiments, whether or not explicitly described. One or more exemplary embodiments have been shown and described, and all variations and modifications within the spirit of this disclosure are intended to be protected.

Claims

1. A device for applying a fluid to the body of an animal, comprising: An intravenous device defining a first fluid passage (354) therethrough, the first fluid passage being configured to selectively deliver IV fluid (314) to and selectively extract bodily fluids (318) from the animal body; and A valve housing defined by the intravenous device defines an outlet (364) configured to connect to a catheter (320) and define a concave distal end surface (706), through which the first fluid passage extends and terminates at the concave distal end surface. Wherein, the maximum depth of the distal end surface of the concave shape is not aligned with the center of the outlet to create a fluid flow pattern, which is the fluid flow pattern after the intravenous device changes from drawing body fluid from the animal's body through the first fluid channel to applying IV fluid to the animal's body through the first fluid channel, removing residual body fluid remaining on the distal end surface of the concave shape. The concave distal end surface defines an asymmetrical funnel-shaped surface (708, 710). Wherein, the longitudinal axis of the first fluid channel is parallel to the longitudinal axis of the conduit.

2. The device according to claim 1 further includes a body fluid port (604) and a fluid extraction component (334), wherein, In the first intravenous device configuration, IV fluid flows through the first fluid channel from the IV fluid port (343) to the body fluid port to administer IV fluid to the animal body, and in the second intravenous device configuration, the body fluid flows into the first fluid channel and through the fluid extraction member.

3. The device according to claim 1, wherein, The center of the first fluid channel is aligned with the point of maximum depth on the distal end surface of the concave shape.

4. The device according to claim 1, wherein, The outlet defines an outer edge, and the center of the first fluid channel is offset from the point of maximum depth of the distal end surface of the concave shape toward the outer edge of the outlet.

5. The device according to claim 1, comprising: A fluid extraction component (334) for extracting the body fluid from the animal's body. The fluid extraction component includes a channel (384) that passively constrains the rate at which the body fluid flows through the fluid extraction component.

6. The device according to claim 1, comprising: A second fluid passage (358), defined by the valve housing, is provided. The second fluid channel is configured to transform the intravenous device's extraction of bodily fluids from the animal's body via the first fluid channel into the delivery of the IV fluid to the animal's body before, during, and after the administration of the IV fluid to the animal's body via the first fluid channel.

7. The device according to claim 6, comprising: A medical tube (360) is fluidly connected to the second fluid channel; and The catheter (320) is connected to the outlet. The medical tube extends outward from the outlet and into the passage within the catheter to deliver the IV fluid to the animal's body.

8. The device according to claim 6, wherein, The body fluid is drawn from the animal's body through the first fluid channel and the IV fluid is simultaneously applied to the animal's body through the second fluid channel.

9. The device according to claim 6, further comprising: Valve component (380); The valve component and the valve housing define the first fluid passage.

10. The device according to claim 1, wherein, The asymmetrical funnel-shaped surface defines a central axis (709), a first surface portion (708), and a second surface portion (710), wherein the first surface portion is inclined at a first angle relative to the central axis and the second surface portion is inclined at a second angle relative to the central axis, the first angle and the second angle being different.

11. The device according to claim 1, wherein, The first fluid channel defines a central axis and the concave distal end surface defines a central axis, wherein the central axis of the concave distal end surface is inclined at 15 to 20 degrees from the central axis of the first fluid channel.

12. The device according to claim 11, wherein, The central axis of the distal end surface of the concave shape is inclined at 20 to 25 degrees from the distal end surface of the concave shape.

13. The device according to claim 1, wherein, The first fluid channel defines a central axis and the distal end surface of the concave shape defines a concave surface (708, 710) and a central axis (709), wherein the central axis of the concave surface is inclined at 15 to 25 degrees from the central axis of the first fluid channel and toward the central axis of the second fluid channel.

14. The device according to claim 1, further comprising: A sealing member (376) defining a concave surface (506, 502) on a first end (504), the concave surface forming the surface of the first fluid channel, wherein the sealing member is configured as follows: A fluid extraction member (334) that extends through the sealing member and enters the first fluid channel through the concave surface. A seal is formed around the fluid extraction member that extends through the sealing member and enters the first fluid channel through the concave surface, and After the fluid extraction member is removed from the sealing member, the residual body fluid and the IV fluid are prevented from leaving the first fluid channel through the sealing member.

15. The device according to claim 14, wherein, The sealing member is defined by an elastomeric material.

16. The device according to claim 14, wherein, The fluid extraction component includes a channel (384) that passively constrains the rate at which the body fluid flows through the fluid extraction component.

17. An apparatus for applying a fluid to the body of an animal, comprising: An intravenous device defining a first fluid passage (354) therethrough, the first fluid passage being configured to selectively deliver IV fluid to and from the animal body; A valve housing defined by the intravenous device defines an outlet (364) configured to connect a catheter to the intravenous device, the outlet defining a concave distal end surface (705), a first fluid channel extending through the outlet and terminating at the concave distal end surface, wherein the shape of the concave distal end surface is configured to generate a fluid flow pattern that removes residual fluid remaining on the concave distal end surface after the intravenous device transitions from drawing the body fluid from the animal body through the first fluid channel to administering IV fluid to the animal body through the first fluid channel, the concave distal end surface defining an asymmetrical funnel-shaped surface (708, 710). and A sealing member (376) defining a concave surface (506, 502) on a first end (504) and coupled to the intravenous device, the concave surface forming the surface of the first fluid channel, and wherein the sealing member is configured as follows: A fluid extraction member (334) that extends through the sealing member and enters the first fluid channel through the concave surface. A seal is formed around the fluid extraction member that extends through the sealing member and enters the first fluid channel through the concave surface, and After the fluid extraction component is removed from the sealing component, fluid is prevented from leaving the first fluid channel through the sealing component. The longitudinal axis of the first fluid channel is parallel to the longitudinal axis of the conduit.

18. The apparatus of claim 17, further comprising: A second fluid passage (358), defined by the valve housing, is provided. The second fluid channel is configured to transport the IV fluid to the animal body before and after the intravenous device draws the body fluid from the animal body through the first fluid channel and then applies the IV fluid to the animal body through the first fluid channel.

19. An intravenous device comprising: Valve housing (340); A valve member (380) and the valve housing define a first fluid passage (354) configured to selectively deliver IV fluid (314) to and from the animal body and extract bodily fluids (318). and An outlet (364), which is coupled to the valve housing and configured to connect to a conduit (320) and defines a concave distal end surface (705), wherein the first fluid channel extends through the outlet and terminates at the concave distal end surface, and wherein the shape of the concave distal end surface is configured to generate a fluid flow pattern that removes residual fluid remaining on the concave distal end surface after the intravenous device changes from drawing the body fluid from the animal body through the first fluid channel to applying the IV fluid to the animal body through the first fluid channel, the concave distal end surface defining an asymmetrical funnel-shaped surface (708, 710). and A sealing member (376) defines a concave surface (506, 502) on a first end (504), the concave surface forming the surface of the first fluid channel, and wherein the sealing member is configured as follows: A fluid extraction member that extends through the sealing member and enters the first fluid channel through the concave surface. A seal is formed around the fluid extraction member that extends through the sealing member and enters the first fluid channel through the concave surface, and After the fluid extraction component is removed from the sealing component, fluid is prevented from leaving the first fluid channel through the sealing component; and A second fluid passage (358), defined by the valve housing, is provided. A medical tube (360) is fluidly connected to the second fluid channel; and A catheter (320) is connected to the outlet, and a medical tube extends outward from the outlet and into a passage (703) within the catheter to deliver the IV fluid to the animal's body; and The second fluid channel is configured to transport the IV fluid to the animal body before, during, and after the intravenous device draws the body fluid from the animal body through the first fluid channel, and after the IV fluid is administered to the animal body through the first fluid channel. The longitudinal axis of the first fluid channel is parallel to the longitudinal axis of the conduit.

Images