BLOOD COLLECTION SYSTEM WITH USER ADJUSTABLE PRESSURE CONTROL AND ASSOCIATED METHODS - Patent application

Abstract

The catheter system may include a catheter adapter, a catheter extending distally from the distal end of the catheter adapter, and a needle hub coupled to the catheter adapter. The needle hub may be transparent, and the needle may be secured within the needle hub. The catheter system may also include a flow control plug coupled to the proximal end of the needle hub. In some embodiments, a flashback path may be disposed between an outer surface of the flow control plug and an inner surface of the needle hub. In some embodiments, the catheter system may include an inner barrel and an outer barrel, and the inner barrel and the needle hub may be configured to move proximally within the outer barrel to retract the needle. The flashback path may be disposed between an outer surface of the needle hub and an inner surface of the inner barrel.

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to blood collection systems with user adjusted pressure management, and related devices and methods. [Background technology]

[0002] Intravenous catheters are commonly used for a variety of infusion therapies. For example, intravenous catheters can be used to infuse fluids, such as saline, various medications, and total parenteral nutrition, into a patient. Intravenous catheters can also be used to collect blood from a patient.

[0003] Common intravenous catheters include peripheral intravenous catheters ("PIVCs"), peripherally inserted central catheters ("PICCs"), and central line catheters. Intravenous catheters may include "over-the-needle" catheters, which are mounted over a needle with a sharp distal tip. The sharp distal tip can pierce the patient's skin and blood vessel. Insertion of an intravenous catheter into a blood vessel can occur after puncture of the vessel with the needle. Needles and intravenous catheters are generally inserted at a shallow angle through the skin into the vascular system with the bevel of the needle facing up and away from the patient's skin.

[0004] To confirm proper placement of the introducer needle and / or IV catheter within the vasculature, a user may typically check and see if there is a flashback of blood. In some embodiments, the introducer needle may include a notch disposed toward the distal end of the introducer needle, and in response to the distal tip of the introducer needle being placed within the vasculature, blood may flow proximally through the needle lumen, exit the needle lumen through the notch, and travel proximally between the exterior surface of the introducer needle and the interior surface of the intravenous catheter.

[0005] Thus, if the intravenous catheter is at least partially transparent, the user may visualize a small amount of blood "flashback" to confirm that the intravenous catheter has been placed within the blood vessel. Indicators of vascular entry, such as flashback, may aid in successful placement of the intravenous catheter. Once placement of the introducer needle within the blood vessel has been confirmed, the user may temporarily block flow within the vessel and withdraw the introducer needle, leaving the intravenous catheter in place for future blood collections or infusions.

[0006] To collect blood, evacuated blood collection tubes may be used. Vacuum blood collection tubes include test tubes with a rubber stopper at one end. Because evacuated blood collection tubes have all or some of the air removed from the test tube, the pressure within the evacuated blood collection tube is less than the ambient pressure. Such evacuated blood collection tubes are often referred to as internal vacuum or evacuated tubes. A commonly used evacuated blood collection tube is the VACUTAINER blood collection tube available from Becton Dickinson & Company.

[0007] To collect a blood sample from a patient, a user first accesses the patient's vein with either a needle or an intravenous catheter. An adapter is coupled to the needle or intravenous catheter. The adapter includes an additional needle that pierces the rubber stopper of the evacuated blood collection tube. Upon piercing the rubber stopper, the pressure in the vein becomes greater than the pressure in the evacuated blood collection tube, forcing blood into the evacuated blood collection tube, causing it to fill with blood. The vacuum in the evacuated blood collection tube decreases as the evacuated blood collection tube fills, until the pressure in the evacuated blood collection tube equals the pressure in the vein and blood flow stops.

[0008] Unfortunately, when blood is drawn into the evacuated blood collection tube, red blood cells are in a state of high shear stress and are prone to hemolysis due to the high initial pressure difference between the vein and the evacuated blood collection tube. Hemolysis may result in rejection and discard of the blood sample. The high initial pressure difference may also result in collapse of the catheter tip, collapse of the vein, or other complications that prevent or limit filling of the evacuated blood collection tube.

[0009] The subject matter claimed herein is not limited to embodiments that solve any shortcomings or that operate only in such environments. Rather, this background is only provided to illustrate one example technology area where some embodiments described herein may be practiced. Summary of the Invention [Means for solving the problem]

[0010] In some embodiments, the blood collection system may include a needle configured to receive a vacuum-type blood collection tube. In some embodiments, the blood collection system may include a blood collection tube container that may surround the needle. In some embodiments, the blood collection system may include an adapter configured to couple to the catheter assembly. In some embodiments, the blood collection system may include a flow regulator disposed between the needle and the adapter. In some embodiments, the flow regulator may be configured to regulate a flow rate through a fluid path of the blood collection system that may extend between the needle and the adapter.

[0011] In some embodiments, the adapter may be coupled to a catheter assembly. In some embodiments, the catheter assembly may also include a catheter adapter, which may include a distal end, a proximal end, and a lumen extending through the distal and proximal ends. In some embodiments, the catheter system may include a catheter extending distally from the distal end of the catheter adapter. In some embodiments, the catheter may be inserted into a patient's vein.

[0012] In some embodiments, the flow regulator may be adjusted to reduce the inner diameter of a portion of the fluid path extending through the flow regulator to less than the inner diameter of the catheter. In some embodiments, after adjusting the flow regulator to reduce the inner diameter of a portion of the fluid path, a needle may be inserted into the evacuated blood collection tube. In some embodiments, when the evacuated blood collection tube is coupled to a blood collection system, blood may flow slower than otherwise due to the reduced inner diameter and the restricted fluid path. When the evacuated blood collection tube is coupled to a blood collection system, the high pressure difference between the evacuated blood collection tube and the vein generally creates a risk of hemolysis. However, in some embodiments, the reduced blood flow due to the reduced inner diameter and the restricted fluid path may reduce the risk of hemolysis. In some embodiments, the reduced blood flow may also reduce the risk of collapse of the vein and / or the catheter.

[0013] In some embodiments, as the evacuated blood collection tube fills with blood, the vacuum in the evacuated blood collection tube is reduced and the pressure difference between the evacuated blood collection tube and the vein is reduced. In some embodiments, the reduced pressure difference may result in the evacuated blood collection tube filling more slowly over time. In some embodiments, in response to the evacuated blood collection tube partially filling with blood, the flow regulator may be adjusted to increase the inner diameter of the fluid path extending through the flow regulator, which may increase blood flow and speed up blood collection. In some embodiments, the inner diameter may be increased to be larger than the inner diameter when the needle is inserted into the evacuated blood collection tube. In some embodiments, the inner diameter may be increased to be equal to (or larger than) the inner diameter of the catheter.

[0014] In some embodiments, the flow regulator may include a rotating element. In some embodiments, in response to the rotating element being in a first position, a portion of a fluid path of the blood collection system may extend through the rotating element. In some embodiments, in response to rotation of the rotating element from the first position to the second position, a diameter of the portion of the fluid path extending through the rotating element may change. In some embodiments, the rotating element may include one or more holes configured to align with the fluid path of the blood collection system. In some embodiments, each of the holes may have a different diameter.

[0015] In some embodiments, the rotating element may include a curved slot extending therethrough. In some embodiments, the entirety of the curved slot may be configured to align with a fluid path of the blood collection system. In some embodiments, the width of the curved slot may increase continuously such that the fluid flow rate through the rotating element changes continuously as the rotating element rotates.

[0016] In some embodiments, the flow regulator may include a stopcock, a throttle valve, or a slide valve. In some embodiments, the slide valve may include a housing and a body slidable relative to the housing between a first position and a second position. In some embodiments, the housing may include a first end, a second end, and a lumen extending through the first end and the second end. In some embodiments, the first end of the housing may include an opening. In some embodiments, the exterior surface of the body may include one or more channels. In some embodiments, in response to the body being in the first position, blood is configured to flow through a gap between the exterior surface of the body and the housing and through the opening. In some embodiments, in response to the housing being in the second position, blood is configured to flow through at least one of the channels and through the opening, but may not flow through the gap.

[0017] In some embodiments, the blood collection system may include a tube that may extend between the adapter and the needle. In some embodiments, the flow regulator may include a clamp disposed on the tube. In some embodiments, the clamp on the tube may include a roller clamp or a slide clamp. In some embodiments, the inner surface of the tube may include one or more ribs that may extend generally parallel to a longitudinal axis of the tube.

[0018] In some embodiments, the slide clamp may include a housing that may include a slot. In some embodiments, the slide clamp may include a body that may extend through the slot. In some embodiments, the body may be slidable relative to the housing between a first position and a second position. In some embodiments, the bottom of the body may include a first surface, a second surface, and a third surface disposed between the first surface and the second surface. In some embodiments, the first surface and the second surface may be generally parallel to a longitudinal axis of the tube. In some embodiments, the third surface may be angled relative to the longitudinal axis of the tube. In some embodiments, the second surface may be closer to the tube than the first surface.

[0019] In some embodiments, the slide clamp may include a roller pin disposed between the body and the tube. In some embodiments, in response to the body being in a first position, the roller pin may contact the first surface and the tube. In some embodiments, in response to the body sliding from the first position to the second position, the roller pin moves from the first surface to the second surface along the third surface to reduce a fluid flow rate through the tube.

[0020] In some embodiments, a particular blood collection tube holder may include one or more of the following: a needle configured to receive a vacuum-type collection tube; a cavity; a tube disposed within the cavity and in fluid communication with the needle; a button disposed within the cavity; and a spring. In some embodiments, the button may include an opening extending through the button. In some embodiments, the button may include a rib proximate the opening. In some embodiments, the tube may extend through the opening.

[0021] In some embodiments, a spring may be disposed between the button and the wall of the cavity. In some embodiments, the spring may bias the rib against the tube to compress the tube. In some embodiments, the tube may be uncompressed in response to the button being pressed and the spring being compressed.

[0022] It is to be understood that the foregoing general description and the following detailed description are exemplary and explanatory and are not restrictive of the claimed invention. It is to be understood that the various embodiments are not limited to the arrangements and instrumentalities shown in the drawings. It is also to be understood that the embodiments may be combined or other embodiments may be utilized, and that structural changes may be made without departing from the scope of the various embodiments of the present invention, unless so claimed. Therefore, the following detailed description is not to be taken in a limiting sense.

[0023] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief description of the drawings]

[0024] [Figure 1A] FIG. 1A is a top perspective view of an exemplary blood collection system, according to some embodiments. [Figure 1B]FIG. 1B is a cross-sectional view of a blood collection system showing an example of a rotating element in a first position, according to some embodiments. [Figure 1C] FIG. 1C is a cross-sectional view of a blood collection system showing an exemplary rotating element in a second position, according to some embodiments. [Figure 1D] FIG. 1D is a top perspective view of a rotating element, according to some embodiments. [Figure 1E] FIG. 1E is a top perspective view of another rotating element, according to some embodiments. [Figure 1F] FIG. 1F is a cross-sectional view of a rotating element, according to some embodiments. [Figure 2A] FIG. 2A is a top perspective view of a blood collection system showing an exemplary roller clamp, according to some embodiments. [Figure 2B] FIG. 2B is a cross-sectional view of a roller clamp, according to some embodiments. [Figure 2C] FIG. 2C is a top perspective view of an exemplary tube, according to some embodiments. [Figure 3A] FIG. 3A is a cross-sectional view of an exemplary slide valve showing a body of the slide valve in a first position according to some embodiments. [Figure 3B] FIG. 3B is a top perspective view of the slide valve showing the body of the slide valve in a first position according to some embodiments. [Figure 3C] FIG. 3C is a cross-sectional view of the slide valve showing the body of the slide valve in a second position according to some embodiments. [Figure 3D] FIG. 3D is a top perspective view of the slide valve showing the body of the slide valve in a second position according to some embodiments. [Figure 3E] FIG. 3E is a top perspective view of a slide valve according to some embodiments. [Figure 4A] FIG. 4A is a top perspective view of a blood collection system showing an exemplary slide clamp, according to some embodiments. [Figure 4B]FIG. 4B is a cross-sectional view of a slide clamp in a first position according to some embodiments. [Figure 4C] FIG. 4C is a cross-sectional view of the slide clamp in a second position according to some embodiments. [Figure 5A] FIG. 5A is a top perspective view of a blood collection system showing an exemplary stopcock, according to some embodiments. [Figure 5B] FIG. 5B is a cross-sectional view of the stopcock in a first position according to some embodiments. [Figure 5C] FIG. 5C is a cross-sectional view of the stopcock in a second position, according to some embodiments. [Figure 5D] FIG. 5D is a cross-sectional view of a stopcock according to some embodiments. [Figure 6A] FIG. 6A is a top perspective view of a blood collection system showing an exemplary pinch clamp, according to some embodiments. [Figure 6B] FIG. 6B is a cross-sectional view of a pinch clamp in a first position according to some embodiments. [Figure 6C] FIG. 6C is a cross-sectional view of the pinch clamp in a second position according to some embodiments. [Figure 6D] FIG. 6D is a cross-sectional view of a pinch clamp, according to some embodiments. [Figure 7A] FIG. 7A is a top perspective view of another blood collection system, according to some embodiments. [Figure 7B] FIG. 7B is a cross-sectional view of another blood collection system, according to some embodiments. [Figure 8A] FIG. 8A is a top perspective view of another blood collection system, according to some embodiments. [Figure 8B] FIG. 8B is a bottom perspective view of an exemplary blood collection tube holder, according to some embodiments. [Figure 8C] FIG. 8C is a side view of a blood collection tube holder, according to some embodiments. [Figure 8D]FIG. 8D is another side view of a blood collection tube holder, according to some embodiments. [Figure 8E] FIG. 8E is a cross-sectional view of the blood collection tube holder taken along line 8E-8E of FIG. 8C, according to some embodiments. [Figure 8F] FIG. 8F is a cross-sectional view of the blood collection tube holder taken along line 8F-8F of FIG. 8D, showing an exemplary button in a first position, according to some embodiments. [Figure 8G] FIG. 8G is a cross-sectional view of the blood collection tube holder taken along line 8F-8F of FIG. 8D, showing the button in a second position, according to some embodiments. [Figure 8H] FIG. 8H is a top perspective view of a button according to some embodiments. [Figure 8I] FIG. 8I is a bottom perspective view of the body of an exemplary blood collection holder, according to some embodiments. [Figure 8J] FIG. 8J is a bottom perspective view of an exemplary tube and an exemplary needle coupled to the tube, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0025] 1A-1D, in some embodiments, blood collection system 10 may include a needle 12 configured to receive a vacuum-type blood collection tube. In some embodiments, blood collection system 10 may include a blood collection tube receptacle 14 that may surround needle 12. In some embodiments, blood collection system 10 may include an adapter 16 configured to couple to a catheter assembly 18. In some embodiments, blood collection system 10 may include a flow regulator 20 disposed between needle 12 and adapter 16. In some embodiments, flow regulator 20 may be configured to regulate a flow rate through a fluid pathway 22 of blood collection system 10 that may extend between needle 12 and adapter 16.

[0026] In some embodiments, the adapter 16 may be coupled to a catheter assembly 18. In some embodiments, the adapter 16 may include a Luer adapter, which may include a Luer lock or Luer slip connector. In some embodiments, the Luer adapter may include a male or female Luer connector. In some embodiments, the catheter assembly 18 may also include a catheter adapter 24, which may include a distal end 26, a proximal end 28, and a lumen 30 extending through the distal end 26 and the proximal end 28. In some embodiments, the catheter system 18 may include a catheter 32 extending distally from the distal end 26 of the catheter adapter 24. In some embodiments, the catheter 32 may be inserted into a vein of a patient. In some embodiments, in response to coupling of the adapter 16 to the catheter adapter 24, a septum 33 disposed within the lumen 30 may be pierced.

[0027] In some embodiments, the catheter system 32 may include a peripheral intravenous catheter system, such as, for example, the BD NEXIVA™ Closed IV Catheter System, the BD CATHENA™ Catheter System, the BD VENFLON™ Pro Safely Shielded IV Catheter System, the BD NEOFLON™ IV Cannula System, the BD INSYTE™ AUTOGUARD™ BC Shielded IV Catheter System, or another suitable peripheral intravenous catheter system. In some embodiments, the catheter tube 32 may include a PICC, or midline catheter. In some embodiments, the adapter 16 may be coupled to the catheter adapter 24 in any number of suitable ways. For example, the adapter 16 may be coupled to the distal end 26 of the catheter adapter 24. As another example, the adapter 16 may be coupled to an extension tube extending outwardly from the catheter adapter 24.

[0028] In some embodiments, the first tube 34 may extend between the adapter 16 and the flow regulator 20, and the second tube 36 may extend between the flow regulator 20 and another adapter 38, which may be configured to couple to a needle assembly 40 that includes the needle 12. In some embodiments, the first tube 34 and / or the second tube 36 may increase flexibility and reduce the risk of disturbing the insertion site of the catheter 32 into the patient. In some embodiments, the first tube 34 and / or the second tube 36 may be coupled to and / or integral with the flow regulator 20.

[0029] In some embodiments, the flow regulator 20 may be adjusted to reduce the inner diameter of the portion of the fluid pathway 22 that extends through the flow regulator 20 to less than the inner diameter of the catheter 32. In some embodiments, after adjusting the flow regulator 20 to reduce the inner diameter of the portion of the fluid pathway 22, the needle 12 may be inserted into an evacuated blood collection tube, which may be evacuated such that the pressure within the evacuated blood collection tube is less than ambient or atmospheric pressure.

[0030] In some embodiments, when a vacuum-type blood collection tube is coupled to the blood collection system 10 via the insertion of the needle 12, blood may flow slower than otherwise due to the reduced inner diameter and the restricted fluid path. Generally, when a vacuum-type blood collection tube is coupled to a blood collection system, the high pressure difference between the vacuum-type blood collection tube and the vein creates a risk of hemolysis. However, in some embodiments, the reduced blood flow due to the reduced inner diameter and the restricted fluid path 22 may reduce the risk of hemolysis. In some embodiments, the reduced blood flow may also reduce the risk of collapse of the vein and / or catheter 32.

[0031] In some embodiments, as the evacuated blood collection tube fills with blood, the vacuum in the evacuated blood collection tube is decreased and the pressure difference between the evacuated blood collection tube and the vein is decreased. In some embodiments, the decreased pressure difference may result in the evacuated blood collection tube filling more slowly over time. In some embodiments, in response to the evacuated blood collection tube partially filling with blood, the flow regulator 20 may be adjusted to increase the inner diameter of the fluid path 22 extending through the flow regulator 20, which may increase blood flow and speed up blood collection. In some embodiments, the inner diameter may be increased to be larger than the inner diameter when the needle 12 is inserted into the evacuated blood collection tube. In some embodiments, the inner diameter may be increased to be equal to (or larger than) the inner diameter of the catheter 32.

[0032] In some embodiments, the flow regulator 20 may include a rotating element 42. In some embodiments, in response to the rotating element 42 being in a first position, a portion of the fluid path 22 of the blood collection system 10 may extend through the rotating element 42. An example of the first position is shown in FIG. 1B. In some embodiments, in response to rotation of the rotating element 42 from the first position to the second position, a diameter of the portion of the fluid path 33 extending through the rotating element 42 may change. An example of the second position is shown in FIG. 1C. In some embodiments, the rotating element 42 may include one or more holes 44 configured to align with the fluid path 22 of the blood collection system 10. In some embodiments, each of the holes 44 may have a different diameter and / or size.

[0033] In some embodiments, when the rotating element 42 is in a first position, the first hole 44a may be aligned with the fluid pathway 22, and when the rotating element 42 is in a second position, the second hole 44b may be aligned with the fluid pathway 22. In some embodiments, the first hole 44a may be smaller than the second hole 44b and may be smaller than the inner diameter of the catheter 32. In some embodiments, the size or inner diameter of the second hole 44b may be between the first hole 44a and the catheter 32. In some embodiments, the size or inner diameter of the second hole 44b may be equal to the catheter 32.

[0034] In some embodiments, the rotatable element 42 may be in the first position prior to coupling the evacuated blood collection tube to the blood collection system 10 or immediately after coupling the evacuated blood collection tube to the blood collection system. In some embodiments, in response to the evacuated blood collection tube being partially filled with blood, a user may rotate the rotatable element 42 to the second position. In some embodiments, the first position may correspond to a closed or partially restricted state. In some embodiments, the second position may facilitate a higher flow rate than the first position.

[0035] In some embodiments, the rotating element 42 may be rotated relative to the body 46 of the flow regulator 20, which may include a distal piece 48 and / or a proximal piece 50. In some embodiments, the rotating element 42 may be coupled to the distal piece 48 and / or the proximal piece 50 via a pin 52. In some embodiments, the pin 52 may extend through the distal piece 48, the rotating element 42, and / or the proximal piece 50. In some embodiments, the rotating element 42 may rotate about the pin 52. In some embodiments, the rotating element 42 may be coupled to the distal piece 48 and / or the proximal piece 50 via any number of suitable methods.

[0036] In some embodiments, the needle assembly 40 may include a Luer adapter, which may include a Luer lock or Luer slip connector. In some embodiments, the Luer adapter may include a male or female Luer connector. In some embodiments, the needle 12 may extend proximally from the Luer adapter. In some embodiments, the needle assembly 40 may include one or more threads, which may be configured to couple to a blood collection tube receptacle 14, which may be generally cylindrical.

[0037] In some embodiments, an elastomeric sheath 54 may be coupled to the needle assembly 40. In some embodiments, a proximal end 56 of the needle 12 may be enclosed within the elastomeric sheath 54. In some embodiments, the elastomeric sheath 54 may include an open distal end 58 and a closed proximal end 60. In some embodiments, in response to the evacuated blood collection tube pushing the elastomeric sheath 54 distally, the needle 12 may penetrate the elastomeric sheath 54 and the needle 12 may be inserted into a cavity of the evacuated blood collection tube.

[0038] In some embodiments, the rotating element 42 may include one or more markings. In some embodiments, the markings may each indicate a catheter gauge size, such as, for example, 18g, 20g, 22g, or 24g. In some embodiments, the distal piece 48 or the proximal piece 50 may include another marking configured to align with the marking of the rotating element 42. In some embodiments, the user may align the particular marking of the rotating element 42 indicating the particular gauge size with the other marking when the catheter 32 being used is of the particular gauge size. In some embodiments, in response to the alignment of the particular marking with the other marking of the rotating element 42, the particular hole 44 may be aligned with the fluid pathway 22. In some embodiments, the particular hole 44 may include an inner diameter smaller than the particular gauge size.

[0039] 1E, in some embodiments, the rotating element 61 may include a curved slot 62 extending therethrough. In some embodiments, the rotating element 61 may be similar or identical to the rotating element 42 discussed with respect to FIGS. 1A-1D in one or more included features and / or operation. In some embodiments, the entirety of the curved slot 62 may be configured to align with the fluid pathway 22 of the blood collection system 10 through rotation of the rotating element 61. In some embodiments, the inner diameter or width of the curved slot 62 may increase continuously such that the fluid flow rate through the rotating element 61 changes continuously as the rotating element 61 rotates.

[0040] In some embodiments, the rotatable element 61 may be in the first position prior to coupling the evacuated blood collection tube to the blood collection system 10 or immediately after coupling the evacuated blood collection tube to the blood collection system. In some embodiments, in response to the evacuated blood collection tube being partially filled with blood, a user may rotate the rotatable element 61 to the second position. In some embodiments, when the rotatable element 61 is in the first position, a portion of the curved slot 62 having a first inner diameter may be aligned with the fluid path 22. In some embodiments, when the rotatable element 61 is in the second position, another portion of the curved slot 62 having a second inner diameter may be aligned with the fluid path 22. In some embodiments, the second inner diameter may be larger than the first inner diameter. In some embodiments, the first position may correspond to a closed or partially restricted state. In some embodiments, the second position may facilitate a higher flow rate than the first position.

[0041] 1F, in some embodiments, the blood collection system 10 may not include the first tube 34 and / or the second tube 36. In some embodiments, the adapter 16 and / or other adapters 38 may be integrally formed with the flow regulator 20.

[0042] 2A-2B, in some embodiments, blood collection system 10 may include tubing 64 that may extend between adapter 16 and needle 12. In some embodiments, tubing 64 may be elastically deformable. In some embodiments, flow regulator 20 may include a clamp disposed on tubing 64. In some embodiments, the clamp on tubing 64 may include a roller clamp 66. In some embodiments, roller clamp 66 may include any suitable roller clamp known in the art.

[0043] In some embodiments, the roller clamp 66 may include a substantially rigid elongated frame 68, generally cylindrical rollers 70, and a length of tube 64 disposed within the frame. In some embodiments, the roller track 72 or frame 68 may be tilted. In some embodiments, the flow rate through the tube 64 may be controlled by moving the generally cylindrical rollers 70 over the tube 64 along the roller track 72, thereby selectively compressing the tube 64 to achieve a desired flow rate.

[0044] In some embodiments, the generally cylindrical rollers 70 may be in a closed or partially restricted state prior to coupling the evacuated blood collection tube to the blood collection system 10 or immediately after coupling the evacuated blood collection tube to the blood collection system 10. In some embodiments, in response to the evacuated blood collection tube being partially filled with blood, the generally cylindrical rollers 70 may be moved by a user from the closed or partially restricted state to a high flow state.

[0045] 2C, in some embodiments, the inner surface of the tube 64 may include one or more ribs 74 or protrusions that may extend generally parallel to the longitudinal axis of the tube 64. In some embodiments, the ribs 74 may prevent complete blockage of the tube 64. In some embodiments, the ribs 74 may maintain a minimum flow rate through the tube 64 even if the tube 64 is clamped or pinched. In some embodiments, the ribs 74 may extend through a portion of the tube 64 disposed within the flow regulator 20. In some embodiments, the ribs 74 may extend along all or a portion of the tube 64.

[0046] 3A-3E, in some embodiments, the flow regulator 20 may include a slide valve 76. In some embodiments, the slide valve 76 may include a housing 78 and a body 80 that is slidable relative to the housing 78 between a first position and a second position. In some embodiments, the housing 78 may include a slot 82, and the body 80 may extend through the slot 82 for grasping by a user.

[0047] In some embodiments, the housing 78 may include a first end 84, a second end 86, and a lumen 88 extending through the first end 84 and the second end 86. In some embodiments, the first end 84 of the housing 78 may include an opening 90. In some embodiments, the first end 84 may be proximal to the second end 86, as shown, and the body 80 may move proximally to close the opening 90. In some embodiments, the first end 84 may be distal to the second end 86, and the body 80 may move distally to close the opening 90.

[0048] In some embodiments, the exterior surface of the body 80 may include one or more channels 92. In some embodiments, in response to the body 80 being in a first position, such as illustrated in FIG. 3A, blood may be configured to flow through a gap 94 between the exterior surface of the body 80 and the housing 78 and through the opening 90. In some embodiments, in response to the housing 78 being in a second position, such as illustrated in FIG. 3C, blood may be configured to flow through at least one of the channels 92 and through the opening 90, but not through the gap 94.

[0049] In some embodiments, the body 80 may be in the first position prior to coupling the evacuated blood collection tube to the blood collection system 10 or immediately after coupling the evacuated blood collection tube to the blood collection system. In some embodiments, the body 80 may be moved by a user from the first position to the second position in response to the evacuated blood collection tube being partially filled with blood. In some embodiments, the first position may correspond to a closed or partially restricted state. In some embodiments, the second position may facilitate a higher flow rate than the first position.

[0050] 3E, in some embodiments, blood collection system 10 may not include first tube 34 and / or second tube 36. In some embodiments, adapter 16 and / or other adapters 38 may be integrally formed with flow regulator 20.

[0051] 4A-4C, in some embodiments, the flow regulator 20 may include a slide valve 76. In some embodiments, the blood collection system 10 may include a tube 64 that may extend between the adapter 16 and the needle 12. In some embodiments, the flow regulator 20 may include a clamp disposed on the tube 64. In some embodiments, the clamp on the tube 64 may include a slide clamp 96.

[0052] In some embodiments, the slide clamp 96 may include a housing 98 that may include a slot 100. In some embodiments, the slide clamp 96 may include a body 102 that may extend through the slot 100. In some embodiments, the body 80 may be slidable relative to the housing 98 between a first position, illustrated, for example, in FIG. 4B, and a second position, illustrated, for example, in FIG. 4C. In some embodiments, the bottom of the body 80 may include a first surface 104, a second surface 106, and a third surface 108 disposed between the first surface 104 and the second surface 106. In some embodiments, the first surface 104 and the second surface 106 may be planar and / or generally parallel to the longitudinal axis of the tube 64. In some embodiments, the third surface 108 may be angled relative to the longitudinal axis of the tube 64. In some embodiments, the second surface 106 may be closer to the tube 64 than the first surface 104.

[0053] In some embodiments, the slide clamp 96 may include a roller pin 110 disposed between the body 102 and the tube 64. In some embodiments, in response to the body 102 being in the first position, the roller pin 110 may contact the first surface 104 and the tube 64. In some embodiments, in response to the body 102 sliding from the first position to the second position, the roller pin 110 moves or rolls from the first surface 104 to the second surface 106 along the third surface 108 to reduce fluid flow through the tube 64. In some embodiments, a fourth surface 112 or stop surface may be disposed at an end of the body 102 and may prevent the roller pin 110 from rolling beyond the end of the body 102.

[0054] In some embodiments, the body 102 may be in the first position prior to coupling the evacuated blood collection tube to the blood collection system 10 or immediately after coupling the evacuated blood collection tube to the blood collection system. In some embodiments, the body 80 may be moved by a user from the first position to the second position in response to the evacuated blood collection tube being partially filled with blood. In some embodiments, the first position may correspond to a closed or partially restricted state. In some embodiments, the second position may facilitate a higher flow rate than the first position.

[0055] 5A-5C, in some embodiments, the flow regulator 20 may include a stopcock 114. In some embodiments, the stopcock 114 may be in a first position prior to coupling the evacuated blood collection tube to the blood collection system 10 or immediately after coupling the evacuated blood collection tube to the blood collection system. In some embodiments, in response to the evacuated blood collection tube being partially filled with blood, the stopcock 114 may be moved by a user from a first position, e.g., as illustrated in FIG. 5B, to a second position, e.g., as illustrated in FIG. 5C. In some embodiments, the first position may correspond to a closed or partially restricted state. In some embodiments, the second position may facilitate a higher flow rate than the first position.

[0056] In some embodiments, in response to rotation of the stopcock 114 from the first position to the second position, a diameter of the portion of the fluid pathway 22 extending through the stopcock 114 may change. In some embodiments, the stopcock 114 may include one or more pairs of holes 116 configured to align with the fluid pathway 22 of the blood collection system 10. In some embodiments, a first hole and a second hole of the pair of holes 116 may be disposed directly opposite one another. In some embodiments, each of the pair of holes 44 may have a different diameter and / or size.

[0057] In some embodiments, when the stopcock 114 is in a first position, the first pair of holes 116a may be aligned with the fluid pathway 22, and when the stopcock 114 is in a second position, the second pair of holes 116b may be aligned with the fluid pathway 22. In some embodiments, the first pair of holes 116a may be smaller than the second pair of holes 116b and may be smaller than the inner diameter of the catheter 32.

[0058] 5D, in some embodiments, blood collection system 10 may not include first tube 34 and / or second tube 36. In some embodiments, adapter 16 and / or other adapters 38 may be integrally formed with flow regulator 20.

[0059] 6A-6C, in some embodiments, the flow regulator 20 may include a pinch valve 118. In some embodiments, the pinch valve 118 may include a body 120 through which the fluid path 22 may extend. In some embodiments, a first end of the pinch valve 118 may be coupled to the first tube 34 and / or a second end of the pinch valve 118 may be coupled to the second tube 36. In some embodiments, the pinch valve 118 may be elastically deformable.

[0060] In some embodiments, in response to a user pinching body 120, fluid pathway 22 may close or be partially restricted. In some embodiments, a user may pinch body 120 prior to coupling the evacuated blood collection tube to blood collection system 10 or immediately after coupling the evacuated blood collection tube to the blood collection system. In some embodiments, in response to the evacuated blood collection tube being partially filled with blood, a user may pinch body 120 less or stop pinching body 120, causing flow through fluid pathway 22 to increase.

[0061] 6D, in some embodiments, the blood collection system 10 may not include the first tube 34 and / or the second tube 36. In some embodiments, the adapter 16 and / or other adapters 38 may be integrally formed with the flow regulator 20.

[0062] 7A-7B, a blood collection system 122 is shown, according to some embodiments. In some embodiments, the blood collection system 122 may be similar or identical to the blood collection system 10 discussed with respect to FIGS. 1A-6D in terms of one or more included features and / or operation. As previously mentioned, in some embodiments, the adapter 16 may be coupled to the catheter adapter 24 in any number of suitable ways. FIGS. 7A-7B illustrate the adapter 16 coupled to an extension tube 124 extending outwardly from the catheter adapter 24. In some embodiments, the adapter 16 may include a blunt cannula that may be inserted into a needleless connector 126. The flow regulator 20 includes a pinch valve 118 in FIGS. 7A-7B, although it is understood that in some embodiments, any of the flow regulators 20 of the present disclosure may be used in the blood collection system 122. In some embodiments, the first tube 34 or tube 64 may extend proximally from the adapter 16 to improve flexibility.

[0063] 8A-8J, in some embodiments, blood collection tube holder 127 may include one or more of the following: needle 12 configured to receive a vacuum-type collection tube; a cavity 128 in body 129; a tube 130 disposed within cavity 128 and in fluid communication with needle 12; a button 132 disposed within cavity 128; and one or more springs 134. In some embodiments, button 132 may include an opening 136 extending therethrough. In some embodiments, button 132 may include a rib 138 proximate opening 136. In some embodiments, tube 130 may extend through opening 136. In some embodiments, body 129 may include a blood collection tube receptacle 14.

[0064] In some embodiments, the spring 134 may be disposed between the button 132 and the wall 140 of the cavity 128. In some embodiments, the spring 134 may bias the ribs 138 against the tube 130, compressing the tube 130. In some embodiments, in response to the button 132 being pressed, the spring 134 and the tube 130 may be compressed. In some embodiments, when the tube 130 is compressed, the fluid pathway 22 may be closed or partially restricted. In some embodiments, in response to the evacuated blood collection tube being partially filled with blood, a user may press button 132. In some embodiments, the distal end of body 129 may include a luer adapter.

[0065] All examples and conditional language described herein are intended for educational purposes to aid in understanding the invention and concepts provided by the inventor to advance the technology, and should be construed as not being limited to the specifically recited examples and conditions. Although the embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions, and alterations can be made therein without departing from the spirit and scope of the present invention.

Claims

1. 1. A blood collection system comprising: a needle configured to receive an evacuated blood collection tube; an adapter configured to couple to the catheter assembly; a flow regulator disposed between the needle and the adapter and configured to regulate flow through a fluid pathway extending between the needle and the adapter; Equipped with The flow regulator comprises a rotating element, in response to the rotating element being in a first position, a portion of the fluid path of the blood collection system extends through the rotating element, and in response to the rotating element rotating from the first position to a second position, a diameter of the portion of the fluid path extending through the rotating element changes.

2. The blood collection system of claim 1 , wherein the rotating element includes a plurality of holes configured to align with the fluid paths of the blood collection system, each of the plurality of holes having a different diameter.

3. 2. The blood collection system of claim 1, wherein the rotating element comprises a curved slot extending therethrough, the entirety of the curved slot being configured to align with the fluid path of the blood collection system, and the width of the curved slot continuously increases as the rotating element is rotated such that fluid flow through the rotating element continuously changes.

4. The blood collection system of claim 1 , further comprising a tube extending between the adapter and the needle, and a clamp disposed on the tube.

5. The blood collection system of claim 4 , wherein an inner surface of the tube includes a plurality of ribs extending generally parallel to a longitudinal axis of the tube.

6. The blood collection system of claim 4 , wherein the clamp comprises a roller clamp.

7. The blood collection system of claim 4 , wherein the clamp comprises a slide clamp.

8. The slide clamp is a housing having a slot; a body extending through the slot and slidable relative to the housing between a first position and a second position, a bottom of the body including a first surface, a second surface, and a third surface disposed between the first and second surfaces, the first and second surfaces being generally parallel to a longitudinal axis of the tube, the third surface being angled with respect to the longitudinal axis of the tube, and the second surface being closer to the tube than the first surface; a roller pin disposed between the body and the tube, wherein in response to the body being in the first position, the roller pin contacts the first surface and the tube, and in response to the body sliding from the first position to the second position, the roller pin moves from the first surface to the second surface along the third surface, reducing a fluid flow rate through the tube; 8. The blood collection system of claim 7, comprising:

9. A blood collection system comprising: a needle configured to receive an evacuated blood collection tube; an adapter configured to couple to the catheter assembly; a flow regulator disposed between the needle and the adapter and configured to regulate flow through a fluid pathway extending between the needle and the adapter; Equipped with 11. A blood collection system comprising: a flow regulator comprising a slide valve, the slide valve comprising a housing and a body slidable relative to the housing between a first position and a second position, the housing comprising a first end, a second end, and an inner lumen extending through the first end and the second end, the first end of the housing comprising an opening, an outer surface of the body comprising a plurality of channels, and configured such that in response to the body being in the first position, fluid flows through a gap between the outer surface of the body and the housing and flows through the opening, and in response to the housing being in the second position, fluid flows through at least one of the plurality of channels and does not flow through the opening.

10. The blood collection system of claim 1 , wherein the flow regulator comprises a stopcock.

11. The blood collection system of claim 1 , wherein the flow regulator comprises a metering valve.

12. The blood collection system of claim 1 further comprising a blood collection tube receptacle, said blood collection tube receptacle surrounding said needle.

13. The catheter assembly further comprises: a catheter adapter including a distal end, a proximal end, and a lumen extending through the distal end of the catheter adapter and through the proximal end of the catheter adapter; a catheter extending distally from the distal end of the catheter adapter; 2. The blood collection system of claim 1, comprising:

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