Blood collection set, and related system and method

Abstract

To provide a blood collection set and a related system.SOLUTION: There is provided a system including: an extension set including a catheter adapter having a distal end, a proximal end, and a lumen extending through the distal end and the proximal end of the catheter adapter, the distal end configured to be joined to the proximal end of the catheter adapter, and the proximal end; and a needle assembly joined to the proximal end of the extension set, and including a body, a sharp needle extending proximally from the body, and a sheath for covering a proximal tip of the sharp needle.SELECTED DRAWING: Figure 1A

Description

[Background technology]

[0001] Catheters are typically used for parenteral nutrition, intravenous fluid replacement, and administration of pain medications and antibiotics. Catheters are also used for blood draws. Catheters can be inserted at the bedside using sterile techniques and can remain in place for several weeks.

[0002] A common type of catheter is an over-the-needle catheter. As the name suggests, an "over-the-needle" catheter may be mounted on an introducer needle having a sharp distal tip. The sharp distal tip may be used to pierce a patient's skin and vein. Insertion of the catheter into a vein may follow piercing of the vein by the introducer needle. The introducer needle typically has a sharp distal tip to pierce the patient's skin and vein with minimal resistance to minimize pain to the patient.

[0003] The introducer needle is generally positioned at a steep angle relative to the surface of the skin and the longitudinal dimension of the vein to be penetrated to allow penetration through the skin and vein wall. The needle and catheter are generally inserted with the introducer needle bevel facing away from the patient's skin. After the introducer needle tip penetrates the wall, the angle of insertion is reduced to allow the introducer needle and catheter to slide a distance to securely place the catheter within the vein.

[0004] Once placement of the introducer needle within the vein is confirmed, the introducer needle may be withdrawn and removed, leaving the catheter in place for future fluid infusion and / or blood withdrawal. After blood is withdrawn through the catheter, the catheter system, including the catheter, may be flushed to remove any residual blood. The catheter system may then be used for infusion. However, this process can be time-consuming and dangerous because multiple steps are required to perform blood collection and infusion. Inherent in each process step is the risk of contamination from residual blood. Additionally, the flushing process to remove residual blood from the catheter system tends to be time-consuming and unreliable because grooves and recesses in the components of the catheter system tend to retain residual blood and / or fluid even after flushing.

[0005] 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

[0006] The present disclosure generally relates to blood collection sets and related devices, systems, and methods. In some embodiments, the blood collection set may be coupled to a catheter system. In some embodiments, the catheter system may include a catheter adapter, which may include a distal end, a proximal end, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter. 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 include a peripheral intravenous catheter, a peripherally inserted central catheter, or a midline catheter.

[0007] In some embodiments, the catheter system may include a connector that may be coupled to the catheter adapter. In some embodiments, the connector may include a septum. In some embodiments, the septum may include a slit. In other embodiments, the septum may not include a slit.

[0008] In some embodiments, the blood collection set may include a needle assembly and / or a housing. In some embodiments, the needle assembly may include a body, a sharpened needle extending proximally from the body, and a sheath covering the proximal tip of the sharpened needle. In some embodiments, the housing may be coupled to a connector. In some embodiments, the housing may be configured to create a fluid pathway through the connector.

[0009] In some embodiments, the housing may be directly and removably coupled to the needle assembly. In these and other embodiments, the blood collection set may be used for blood collection via the needle assembly and for injection after removal of the needle assembly from the housing. In some embodiments, the housing may be integral with the needle assembly. More particularly, the housing may be permanently coupled to the needle assembly or may be monolithically formed with the body of the needle assembly as a single unit.

[0010] In some embodiments, the catheter system may include a side port disposed between the distal end of the catheter adapter and the proximal end of the catheter adapter. In some embodiments, the catheter system may include an extension tube. In some embodiments, the catheter system may include an adapter, which may include a distal end and a port. In some embodiments, the adapter may include a Y adapter, a straight adapter, or another suitable adapter. In some embodiments, the extension tube may include a distal end integrated with the side port of the catheter adapter and / or a proximal end integrated with the distal end of the adapter.

[0011] In some embodiments, the connector may include a needleless connector. In some embodiments, the housing may be disposed in a proximal position. In some embodiments, the housing may include a male luer. In some embodiments, the male luer may be configured to activate a septum and create a fluid path through the connector in response to the housing being moved from the proximal position to the distal position. In some embodiments, the housing may be threaded or pushed from the proximal position to the distal position.

[0012] In some embodiments, the housing may include a distal piece and a proximal piece movable distally toward the distal piece. In some embodiments, the distal piece of the housing may include a male luer. In some embodiments, the male luer may be configured to actuate a septum and create a fluid path through the connector in response to distal movement of the proximal piece toward the distal piece.

[0013] In some embodiments, the housing may include a cannula configured to penetrate a septum of the connector to create a fluid pathway through the connector. In some embodiments, the cannula may extend through the septum. In some embodiments, the cannula may include one or more side holes in fluid communication with a lumen of the cannula. In some embodiments, the housing may be movable from a proximal position to a distal position. In some embodiments, in response to the housing moving from a proximal position to a distal position, the cannula may extend through the septum and a fluid pathway through the connector may be created.

[0014] In some embodiments, the catheter system may include an extension set, which may include a distal end coupled to the proximal end of the catheter adapter and / or a proximal end coupled to a connector. In these and other embodiments, the connector may include a needleless connector.

[0015] In some embodiments, the system may include an extension set. In some embodiments, the distal end of the extension set may be configured to couple to the proximal end of the catheter adapter. In some embodiments, the system may include a needle assembly. In some embodiments, the needle assembly may be directly coupled to the proximal end of the extension set. In some embodiments, the system may include a catheter system. In some embodiments, the system may include a catheter adapter and a catheter extending distally from the distal end of the catheter adapter. In some embodiments, the system may include a needleless connector directly coupled to the proximal end of the extension set. In some embodiments, the system may include a housing, which may be directly coupled to the needleless connector and the needle assembly. In some embodiments, the housing may be configured to create a fluid pathway through the needleless connector.

[0016] In some embodiments, the method may include inserting a catheter of the catheter system into the patient's vascular system. In some embodiments, the method may include coupling a blood collection set to the catheter system. In some embodiments, the housing may include a male luer. In some embodiments, the housing may be disposed at a proximal position, and the method may include moving the housing from the proximal position to a distal position. In some embodiments, the male luer may actuate a septum and create a fluid path through the connector in response to the housing being moved from the proximal position to the distal position. In some embodiments, the housing may be threaded from the proximal position to the distal position or may be pushed from the proximal position to the distal position. In some embodiments, the method may further include drawing blood from the patient after moving the housing from the proximal position to the distal position.

[0017] In some embodiments, the housing may include a distal piece and a proximal piece movable distally toward the distal piece. In some embodiments, the distal piece of the housing may include a male luer. In some embodiments, the method may include moving the proximal piece distally toward the distal piece. In some embodiments, the male luer may actuate a septum and create a fluid path through the connector in response to the proximal piece moving distally toward the distal piece. In some embodiments, the method may further include drawing blood from the patient after moving the proximal piece toward the distal piece.

[0018] In some embodiments, the housing may include a cannula, and the cannula may extend through the septum in response to coupling the blood collection set to the catheter system. In some embodiments, the method may include drawing blood from the patient through the blood collection set.

[0019] In some embodiments, the housing may include a cannula, and the method may include moving the housing from a proximal position to a distal position. In some embodiments, in response to the housing moving from the proximal position to the distal position, the cannula may extend through the septum, and a fluid path through the connector may be created. In some embodiments, the method may further include drawing blood from the patient after moving the housing from the proximal position to the distal position.

[0020] In some embodiments, the method may include coupling an extension set to the proximal end of the catheter adapter. In some embodiments, the extension set may include a distal end and a proximal end. In some embodiments, the method may include coupling the distal end of the extension set to the proximal end of the catheter adapter. In some embodiments, the method may include coupling a needle assembly to the proximal end of the extension set and drawing blood from the patient. In some embodiments, the method may include coupling a connector to the proximal end of the extension set and / or coupling a blood draw set to the connector. In some embodiments, the method may further include drawing blood through the extension set.

[0021] In some embodiments, the method may include the steps of detaching the needle assembly from a blood collection set coupled to the catheter system, and flushing or injecting a fluid through the catheter system after detaching the needle assembly from the blood collection set.

[0022] As used in this disclosure, the term "coupling" may include, but is not limited to, direct coupling. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present disclosure. It is to be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings. It is also to be understood that 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 disclosure, unless so claimed. Therefore, the following detailed description is not to be taken in a limiting sense. [Brief explanation of the drawings]

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

[0024] [Figure 1A] FIG. 1 is a top perspective view of an exemplary catheter system, according to some embodiments. [Figure 1B] FIG. 1 is a top perspective view of an exemplary blood collection system, according to some embodiments. [Figure 1C] 1 is a cross-sectional view of a blood collection set, according to some embodiments. [Figure 1D] FIG. 1 is another cross-sectional view of a blood collection set, according to some embodiments. [Figure 2A] FIG. 1 is a top perspective view of a catheter system showing the coupling of an exemplary blood collection tube to the catheter system, according to some embodiments. [Figure 2B] 1 is a cross-sectional view of a blood collection set coupled to an exemplary connector, according to some embodiments. [Figure 3] FIG. 1 is a top perspective view of a catheter system showing an engaged exemplary pinch clamp and an exemplary needle assembly of a detached blood collection set, according to some embodiments. [Figure 4] 1 is a top perspective view of an exemplary adapter coupled to a connector and an exemplary housing of a blood collection set, according to some embodiments. [Figure 5] FIG. 1 is a top perspective view of an exemplary catheter system coupled to a syringe, according to some embodiments. [Figure 6A] FIG. 1 is a side view of a connector according to some embodiments. [Figure 6B] 1 is a cross-sectional view of a connector according to some embodiments. [Figure 7] FIG. 1 is a cross-sectional view of a portion of a catheter system coupled to a syringe, according to some embodiments. [Figure 8] FIG. 1 is a top perspective view of a portion of a catheter system coupled to an exemplary infusion set, according to some embodiments. [Figure 9] FIG. 1 is a top perspective view of a catheter system showing removal of the housing, according to some embodiments. [Figure 10] FIG. 1 is an enlarged perspective view of a housing of a blood collection set, according to some embodiments. [Figure 11] FIG. 10 is a top perspective view of a portion of a catheter system showing removal of another exemplary needle assembly and an exemplary blood control septum, according to some embodiments. [Figure 12A] FIG. 1 is an enlarged perspective view of a portion of a catheter system showing an exemplary proximally positioned blood collection set, according to some embodiments. [Figure 12B] FIG. 1 is an enlarged perspective view of a catheter system showing an exemplary distally positioned blood collection set, according to some embodiments. [Figure 13A] 1A-1C are top perspective views of an exemplary needleless connector, according to some embodiments. [Figure 13B] FIG. 10 is a top perspective view of another exemplary needleless connector, according to some embodiments. [Figure 13C] FIG. 10 is a top perspective view of another exemplary blood collection set configured to couple to a needleless connector, according to some embodiments. [Figure 13D] FIG. 13D is a cross-sectional view of the blood collection set of FIG. 13C, according to some embodiments. [Figure 13E] FIG. 13D is a top perspective view of the blood collection set of FIG. 13C showing another exemplary housing removed from the needle assembly, according to some embodiments. [Figure 14A] FIG. 13D is a side view of another exemplary housing of the blood collection set of FIG. 13C, showing the luer lock, according to some embodiments. [Figure 14B] FIG. 14B is a side view of the housing of FIG. 14A coupled to a needle assembly, showing the luer slip, according to some embodiments. [Figure 14C] FIG. 10 is a close-up perspective view of a luer slip coupled to a needleless connector, according to some embodiments. [Figure 14D]13C coupled to the needleless connector of FIG. 13A, showing the blood collection set in an exemplary proximal position, according to some embodiments. [Figure 14E] 13C coupled to the needleless connector of FIG. 13A, showing the blood collection set in an exemplary distal position, according to some embodiments. [Figure 15A] FIG. 1 is a top perspective view of a catheter system showing another exemplary blood collection set, according to some embodiments. [Figure 15B] 15B is a perspective view of the blood collection set of FIG. 15A showing an exemplary distal piece in a first position, according to some embodiments. [Figure 15C] 15B is a cross-sectional view of the blood collection set of FIG. 15A coupled to an exemplary needleless connector, showing the distal piece in an exemplary first position, according to some embodiments. [Figure 15D] 15B is a perspective view of the blood collection set of FIG. 15A showing the distal piece in an exemplary second position, according to some embodiments. [Figure 15E] 15B is a cross-sectional view of the blood collection set of FIG. 15A showing the distal piece in a second position, according to some embodiments. [Figure 16] FIG. 1 is a top perspective view of a catheter system showing an exemplary adapter with an exemplary injection port, according to some embodiments. [Figure 17A] 17 is an enlarged perspective view of the injection port of FIG. 16 showing an exemplary cap, according to some embodiments. [Figure 17B] FIG. 17 is an enlarged perspective view of the injection port of FIG. 16 showing the cap opened, according to some embodiments. [Figure 18] FIG. 1 is a top perspective view of a catheter system showing an exemplary straight adapter, according to some embodiments. [Figure 19] FIG. 10 illustrates a close-up perspective view of an exemplary elongated end cap coupled to an exemplary adapter, according to some embodiments. [Figure 20]FIG. 1 is a top perspective view of a catheter system showing an exemplary secondary flashback chamber, according to some embodiments. [Figure 21A] FIG. 1 is a close-up top view of an exemplary cannula tip, according to some embodiments. [Figure 21B] FIG. 21B is an enlarged top perspective view of the cannula tip of FIG. 21A, according to some embodiments. [Figure 22A] FIG. 10 is an enlarged top view of another exemplary cannula tip, according to some embodiments. [Figure 22B] FIG. 22B is an enlarged top perspective view of the cannula tip of FIG. 22A according to some embodiments. [Figure 23A] FIG. 1 is a top perspective view of a catheter system showing an exemplary extension set coupled to a blood collection set, according to some embodiments. [Figure 23B] FIG. 13D is a top perspective view of a catheter system showing an extension set coupled to the blood collection set of FIG. 13C, according to some embodiments. [Figure 23C] FIG. 15B is a top perspective view of a catheter system showing an extension set coupled to the blood collection set of FIG. 15A, according to some embodiments. [Figure 24] FIG. 1 is a top perspective view of a catheter system showing an extension set coupled to the proximal end of an exemplary catheter adapter, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0025] 1 , in some embodiments, a catheter system 100 may include a catheter adapter 102 that may include a proximal end 104, a distal end 106, and a lumen 108 extending therebetween. In some embodiments, a side port 110 may be disposed between the distal end 106 of the catheter adapter 102 and the proximal end 104 of the catheter adapter 102. In these and other embodiments, a catheter 112 may extend distally from the distal end 106 of the catheter adapter 102.

[0026] In some embodiments, the catheter 112 may comprise a peripheral intravenous catheter, a peripherally inserted central catheter, or a midline catheter. In some embodiments, the needle hub 134 may be removably coupled to the proximal end 104 of the catheter adapter 102. In some embodiments, the catheter 112 may comprise an over-the-needle catheter such that the introducer needle 132 may extend from the needle hub 134 and through the catheter 112 to insert the catheter system 100 into the patient's vasculature. In some embodiments, the catheter 112 and introducer needle 132 may be assembled such that a sharp proximal tip of the introducer needle 132 extends beyond the distal tip of the catheter 112 and a bevel of the introducer needle 132 points away from the patient's skin.

[0027] In some embodiments, the introducer needle 132 and catheter 112 may be inserted through the skin into the patient's vascular system at a shallow angle. In some embodiments, in response to the introducer needle 132 and catheter 112 being inserted into the patient's vascular system, blood may flow through the introducer needle 132 and into the needle hub 134, and blood may be visible in the needle hub 134, indicating to the user that the introducer needle 132 is in the patient's vascular system.

[0028] In some embodiments, the catheter system 100 may include an adapter 114. In some embodiments, the adapter 114 may include a Y adapter, a straight adapter, or another suitable adapter. In some embodiments, the adapter 114 may include one or more of a distal end 116, a first port 118, and a second port 120. In some embodiments, the adapter 114 may include a reduced volume and / or reduced dimensions relative to standard adapters to avoid blood contamination. In some embodiments, in response to insertion of the catheter 112 into a patient's vasculature, blood may flow through the catheter 112, at least a portion of the catheter adapter 102, the extension tube 122, and into the adapter 114.

[0029] In some embodiments, a port of the adapter 114 may be coupled to the connector 128. In some embodiments, the first port 118 and / or the second port 120 of the adapter 114 may be coupled to the connector 128. More specifically, in some embodiments, the connector 128 may be monolithically formed as a single unit with the first port 118 and / or the second port 120. In other embodiments, the first port 118 and / or the second port 120 of the adapter 114 may be coupled to the connector 128 via a luer connection. In these embodiments, the connector 128 may include a luer, such as, for example, a female luer or a male luer. In some embodiments, the luer may be threaded or slip-fit ​​into the adapter 114.

[0030] In some embodiments, the catheter system 100 may include an extension tube 122, which may include a distal end 124 integrated with the side port 110 and a proximal end 126 integrated with the distal end 116 of the adapter 114. In some embodiments, a clamp, such as, for example, a pinch clamp 136 or another suitable clamp, may be disposed on the extension tube 122 and configured to selectively clamp the extension tube 122 to close a fluid path through the extension tube 122. In some embodiments, the pinch clamp 136 may be replaced with any suitable clamp.

[0031] In some embodiments, connector 128 may include a proximal end configured to receive blood collection set 200. Some embodiments of blood collection set 200 may include a needle assembly 202 and a housing 204, which may be configured to engage connector 128. In some embodiments, housing 204 may be cylindrical. In some embodiments, blood collection set 200 may be used for one or more of drawing, flushing, and infusing blood from a patient.

[0032] 1A-1C , in some embodiments, needle assembly 202 of blood collection set 200 may include a body 212, a sharpened needle 214 extending proximally from body 212, and a sheath 216 covering a sharpened proximal tip 218 of sharpened needle 214. In some embodiments, sheath 216 may be elastomeric. In some embodiments, sheath 216 may be plastic or another suitable material. In some embodiments, sharpened needle 214 may be secured within body 212 via a press fit, adhesive, a mechanical device, or another suitable mechanism. In some embodiments, sharpened needle 214 may extend proximally beyond body 212.

[0033] In some embodiments, sheath 216 may be coupled to body 212 of needle assembly 202. In some embodiments, sharpened proximal tip 218 of sharpened needle 214 may be enveloping within sheath 216. In some embodiments, sheath 216 may include an open distal end and a closed proximal end.

[0034] 1C, in some embodiments, housing 204 and body 212 may be removably coupled together and separable. In these and other embodiments, blood collection set 200 may be used for blood collection via needle assembly 202 and injection after removal of needle assembly 202 from housing 204. Referring now to FIG. 1D, housing 204 and body 212 of needle assembly 202 may be integrated or monolithically formed as a single unit.

[0035] 2A , in some embodiments, the housing 204 and blood collection set 200 may be pre-attached to the connector 128 and catheter system 100. In some embodiments, the catheter system 100 may include the housing 204 assembled and pre-attached to the connector 128. In other embodiments, a user may couple the blood collection set 200 to the connector 128. In some embodiments, the blood collection set 200 may be configured to accept a blood collection device 306, such as, for example, a blood collection tube. In some embodiments, in response to the blood collection device 306 pushing the sheath 216 distally toward the body 212, the sharpened needle 214 may penetrate the sheath 216, and the sharpened proximal tip 218 of the needle assembly 202 may be inserted into the blood collection device 306.

[0036] In some embodiments, inserting the sharp proximal tip 218 into the blood collection device 306 may couple the blood collection device 306 to the blood collection set 200. In some embodiments, the blood collection device 306 may be coupled to the blood collection set 200 after the catheter 112 is positioned within the vasculature. In some embodiments, when the blood collection device 306 is pierced by the sharp proximal tip 218, blood may flow into the blood collection device 306 due to a pressure differential between the vasculature and the blood collection device 306. In some embodiments, the needle assembly 202 may include threads 308 that may be coupled to corresponding threads on a cylindrical holder (not shown) for the blood collection device 306.

[0037] 2B, in some embodiments, the proximal end of connector 128 may include a septum 206, which may be coupled to a body 207 of connector 128. In some embodiments, body 207 may be rigid or semi-rigid. In some embodiments, septum 206 may be constructed of an elastomeric and / or resilient material. In these and other embodiments, septum 206 may or may not include a slit.

[0038] In some embodiments, housing 204 may include cannula 210 configured to pierce or extend through septum 206 to provide a fluid path through connector 128. In these and other embodiments, the tip of cannula 210 may be disposed within housing 204, which may reduce the risk of injury to a user. In some embodiments, the tip of cannula 210 may be blunt, which may reduce the risk of damage to connector 128, or sharp, which may facilitate penetration of septum 206. In some embodiments, cannula 210 may extend distally from housing 204, and the proximal end of cannula 210 may be secured within housing 204 via a press fit, adhesive, a mechanical device, or another suitable mechanism.

[0039] In some embodiments, cannula 210 may be constructed of metal or another suitable material. In some embodiments, the outer diameter of cannula 210 may be uniform along all or part of the length of cannula 210. In some embodiments, the portion of housing 204 through which cannula 210 extends may be constructed of plastic or another suitable material. In some embodiments, proximal end 220 and / or the cylindrical portion of housing 204 surrounding cannula 210 may be constructed of plastic or another suitable material.

[0040] In some embodiments, the proximal end 220 of the housing 204 may include a luer 302 configured to mate with a corresponding luer on the needle assembly 202. Some embodiments of the luer 302 may include, for example, a female luer or a male luer. In some embodiments, the luer 302 may be a threaded or slip fit.

[0041] 3 , in some embodiments, before removing the cannula 210 from the septum 206 and the needle assembly from the catheter system 100, a user may first engage the pinch clamp 136 disposed on the extension tube 122 to stop fluid flow through the fluid path of the catheter system 100, which may extend from the catheter 112, through the extension tube 122, through the adapter 114, through the connector 128, through the cannula 210, and into the needle assembly 202. In some embodiments, the needle assembly 202 may be removed from the catheter system 100 after blood has been collected into the blood collection device 306 and / or after the pinch clamp 136 has been engaged. In these and other embodiments, the housing 204 and blood collection set 200 may be pre-attached to the connector 128 and catheter system 100. In some embodiments, the catheter system 100 may include the housing 204 assembled and pre-attached to the connector 128.

[0042] 4, there is shown, according to some embodiments, luer 302 on proximal end 220 of housing 204. In some embodiments, needle assembly 202 (see, e.g., FIG. 3) may include a luer, such as, for example, a male luer, for coupling to luer 302.

[0043] 5 , in some embodiments, the needle assembly 202 may be uncoupled from the housing 204, and the syringe 802 may then be coupled to the housing 204. During operation, in some embodiments, the pinch clamp 136 may be disengaged from the extension tube 122 to open a fluid path through the catheter system 100. In some embodiments, the syringe 802 may be coupled to the connector 128 by a threaded luer, a luer slip, a press fit, or the like. In some embodiments, the syringe 802 may be used for flushing or infusion after drawing blood and removing the needle assembly 202. In these and other embodiments, the housing 204 and blood collection set 200 may be pre-attached to the connector 128 and catheter system 100. In some embodiments, the catheter system 100 may include the housing 204 assembled and pre-attached to the connector 128.

[0044] In some embodiments, the syringe 802 may be filled with a fluid 702, such as saline or another suitable fluid, to remove residual blood after blood collection. In some embodiments, the syringe 802 may be actuated by depressing the plunger 706 of the syringe 802 to expel the fluid from the syringe 802 and flush the catheter system 100.

[0045] 6A-6B, the proximal end of connector 128 may include a septum 206, which may be coupled to a body 207 of connector 128. In some embodiments, body 207 may be rigid or semi-rigid. In some embodiments, septum 206 may be constructed of an elastomeric and / or elastic material. In these and other embodiments, septum 206 may or may not include a slit. In some embodiments, cannula 210 (see, e.g., FIGS. 1-5) may pierce or extend through septum 206 to provide a fluid path through connector 128.

[0046] 7 , in some embodiments, the connector 128 may include a septum 206 that may be configured to receive the cannula 210 of the housing 204. In some embodiments, the septum 206 and / or the slit may include dimensions such that the cannula 210 extends through the septum 206. In some embodiments, the distal tip 714 of the cannula 210 may be positioned proximate the distal end 138 of the connector 128. In some embodiments, such positioning of the distal tip 714 may facilitate an effective flushing process by reducing the space within the connector 128. In some embodiments, the distal tip 714 may include an angled bevel 226 that increases fluid flow through the distal tip 714.

[0047] 8 , in some embodiments, the needle assembly 202 may be decoupled from the housing 204, and an extension set 900 may be coupled to the housing 204. In some embodiments, the extension set 900 may include a drip chamber and / or an intravenous bag. In some embodiments, the extension set 900 may be used for flushing or infusion. As mentioned above, in some embodiments, the housing 204 may include a luer 302, such as, for example, a slip or thread male luer connector or a slip or thread female luer connector. In some embodiments, the luer 302 may be coupled to a corresponding luer connector 902 of the extension set 900.

[0048] 9 and 10 , following a flushing and / or injection procedure, in some embodiments, the housing 204 may be removed from the connector 128. To this end, in some embodiments, the pinch clamp 136 may be engaged to clamp the extension tube 122 and thereby close the fluid path. Some embodiments of the needle assembly 202 may be removed by applying a force to the needle assembly 202 in a proximal direction 1100 relative to the connector 128. In other embodiments, the needle assembly 202 may be removed by disengaging a thread or other coupling mechanism from the connector 128.

[0049] 10 , in some embodiments, the distal tip 714 of the cannula 210 is surrounded or otherwise blocked by the housing 204 to enhance safety to the user. In some embodiments, the housing 204 may be cylindrical and substantially rigid. In some embodiments, the distal end 1200 of the housing 204 may extend beyond the distal tip 714 of the cannula 210 to prevent accidental needlestick injuries.

[0050] 11 , in some embodiments, connector 128 may include blood control valve 502 or other suitable blood control technology. In some embodiments, blood control valve 502 may be disposed within housing 204, such that pinch clamp 136 may not be required in some embodiments. Indeed, in some embodiments, blood control valve 502 may make the blood collection, flushing, and / or injection process more efficient by automatically preventing blood exposure upon removal of needle assembly 202, as shown, for example, in FIG. 11 . In these and other embodiments, cannula 211 may extend distally from body 212 of needle assembly 202 and may be part of needle assembly 202. In some embodiments, cannula 211 may be configured to extend through blood control valve 502 in response to coupling needle assembly 202 to housing 204. In some embodiments, cannula 211 may include or correspond in one or more features and / or operations to cannula 210 (see, e.g., FIGS. 1-10 ). In some embodiments, cannula 211 may extend through septum 206. In some embodiments, cannula 211 may extend through blood control valve 502 and / or cannula 210 may extend through septum 206.

[0051] 12A-12B, in some embodiments, the housing 204 may be coupled to the connector 128 at a proximal position where the distal tip 714 of the cannula 210 is adjacent to or contacts the connector 128 without extending through or puncturing the connector 128 or the septum 206, as shown in FIG. 12A, for example. In these and other embodiments, the distal tip 714 may be proximal to the septum 206. In this manner, some embodiments of the catheter system 100 may reduce the risk of leakage by maintaining a closed fluid path throughout the shelf life of the catheter system 100. In some embodiments, the housing 204 may be pre-attached to the connector 128 at a proximal position. In other embodiments, the housing 204 may be pre-attached to the connector 128 with the cannula 210 extending through the septum 206 of the connector 128.

[0052] In some embodiments, the housing 204 may be movable from a proximal position to a distal position, such as that shown in FIG. 12B. In some embodiments, a fluid path through the septum 206 may be opened in response to the housing 204 being in the distal position. In some embodiments, a user may move the housing 204 from the proximal position to the distal position, for example, to push the cannula 210 into and / or through the septum 206 prior to blood collection. In other embodiments, the blood collection set 200 may be packaged with the catheter system 100, assembled together, or attached until ready for use.

[0053] 13A-13B, in some embodiments, the connector 128 may include a needleless connector. In some embodiments, the connector 128 may include, for example, a MAXPLUS™ needleless connector, a MAXZERO™ needleless connector, a BD Q-SYTE™ Luer-activated split septum (available from Becton, Dickinson and Company of Franklin Lakes, New Jersey), a SMARTSITE™ needleless connector (available from Becton, Dickinson and Company of Franklin Lakes, New Jersey), or another suitable connector. In some embodiments, the needleless connector in the catheter system 100 may not be penetrated by the cannula 210, but may be opened via a male luer or another suitable mechanism.

[0054] In some embodiments, connector 128 may facilitate the flushing process by including a proximal end surface 806 that may be substantially flat and / or smooth to avoid collection of residual blood and fluids. In some embodiments, septum 206 may be disposed within body 207 of connector 128. In some embodiments, proximal end surface 806 may interface with or contact syringe 802. In some embodiments, connector 128 may include proximal end 130 and distal end 138.

[0055] 13C-13E, a blood collection set 200 is shown according to some embodiments. In some embodiments, blood collection set 200 may be similar or identical to blood collection set 200 described with respect to FIGS. 1-12, for example, with respect to one or more features and / or operation. In some embodiments, blood collection set 200 may include housing 204. In some embodiments, housing 204 may include male luer 205, which may be configured to couple to proximal end 130 of a needleless connector, for example, as shown in FIGS. 13A-13B. In some embodiments, male luer 205 may be tapered and / or monolithically formed as a single unit with the remainder of housing 203. In some embodiments, housing 203 may be removably coupled to needle assembly 202 or may be monolithically formed with needle assembly 202 as a single unit.

[0056] 14A-14B, in some embodiments, housing 204 may include luer 302 (see, e.g., FIG. 2B) and / or male luer 205, which may be disposed on the interior surface of housing 204. In some embodiments, male luer 205 may include luer lock 402 or luer slip 404. In some embodiments, the protrusion of male luer 205 may extend beyond the cylindrical portion of housing 204, as shown, for example, in FIGS. 13C-13E. In other embodiments, the protrusion of male luer 205 may not extend beyond the cylindrical portion of housing 204 and may be disposed within the cylindrical portion. In some embodiments, male luer 205 may be configured to engage luer 209 (see, e.g., FIGS. 13A-13B) at proximal end 130 of the needleless connector.

[0057] 14C-14E, in some embodiments, housing 204 may be positioned in a proximal position, for example, as shown in Fig. 14D. In these embodiments, connector 128 may be coupled to male luer 205 of housing 204 such that male luer 205 is maintained adjacent to connector 128 but is not inserted into connector 128. As shown in Fig. 14C, in some embodiments, male luer 205 and connector 128 may be spaced apart.

[0058] In some embodiments, housing 204 and / or needle assembly 202 may be movable from a proximal position to a distal position, such as that shown in FIG. 14E. In some embodiments, in response to housing 204 being in the distal position, male luer 205 may be fully inserted into connector 128. In some embodiments, housing 204 may be moved from the proximal position to the distal position by a user prior to performing a blood collection procedure.

[0059] 15A-15E , in some embodiments, housing 204 may include a distal piece 213 and a proximal piece 215 that is movable distally toward distal piece 213. In some embodiments, distal piece 213 of housing 204 may include a male luer 205. For example, as shown in FIGS. 15D-15E , in some embodiments, proximal piece 215 may be moved distally toward distal piece 213. In some embodiments, male luer 205 may actuate septum 206 and create a fluid path through connector 128 in response to proximal piece 215 moving distally toward distal piece 213. In some embodiments, an outer surface of distal piece 213 may include one or more protrusions 217, which may facilitate fixation of proximal piece 215, for example, in a proximal position shown in FIG. 15C and / or a distal position shown in FIG. 15E . In some embodiments, the inner surface of the housing 204 may include one or more protrusions 219 configured to slide past the protrusions 217 and engage the proximal piece 215 with the distal piece 213 in a snap fit. In some embodiments, the protrusions 219 may be disposed on the inner surface of the arms 221 of the proximal piece 215 of the housing 204, which may be detached from the remainder of the proximal piece 215 along opposing edges and the ends of the arms 221 to provide flexion.

[0060] 16, 17A, and 17B, in some embodiments, the adapter 114 may include an injection port 408 configured to accept a syringe 802 (see, e.g., FIG. 5) or other suitable injection or collection device. In some embodiments, the adapter 114 may be straight, as shown, or the adapter 114 may include a Y-adapter or another suitable shape. In some embodiments, the connector 128 may be needleless or may be configured to accept a cannula 210. In some embodiments, the adapter 114 may include a blood control valve 409 disposed within the lumen 222 of the adapter 114, which may seal the injection port 408.

[0061] In some embodiments, the injection port cap 410 may be coupled to the injection port 408 to avoid contamination of the injection port 408 and / or the blood control valve 409. Some embodiments of the injection port cap 410 may include a hinge 411 or other suitable connection device to maintain the injection port cap 410 in proximity to the injection port 408. Some embodiments of the injection port cap 410 may include dimensions and locking features to facilitate easy opening and secure closure of the injection port 408. In some embodiments, the injection port cap 410 may be press-fit onto the injection port 408 to selectively close access to the adapter 114. Referring now to FIG. 18 , according to some embodiments, the adapter 114 is shown in a straight configuration and without the injection port 408.

[0062] 19 , in some embodiments, a particular port of the adapter 114, such as the second port 120 of the adapter 114, may include an elongated end cap 500. In some embodiments, the elongated end cap 500 may extend even with or distal to the inner wall 501 that forms the lumen 504 of the first port 118. In this manner, some embodiments of the adapter 114 may reduce blood contamination of the second port 120. In some embodiments, the elongated end cap 500 may be disposed within the lumen 506 of the second port 120. In some embodiments, the connector 128 may be needleless or may be configured to accept a cannula 210.

[0063] 20 , in some embodiments, the catheter system 100 may include a secondary flashback chamber 600 disposed at the proximal end 104 of the catheter adapter 102. During operation, in some embodiments, placement of the catheter 112 within the vasculature may be confirmed by visible blood or an “instablash” within the catheter 112 and / or the primary flashback chamber within the catheter adapter 102. In some embodiments, the secondary flashback chamber 600 may facilitate observation of blood within the secondary flashback chamber 600 to enhance initial vein confirmation as well as facilitate continued placement of the catheter 112 within the vein during blood draws, flushes, or infusions.

[0064] In some embodiments, upon confirmation of proper placement of the catheter 112 within the vein, the needle assembly 202 and / or housing 204 of the blood collection set 200 may be engaged with the connector 128 to open a fluid pathway for blood collection. After blood collection, in some embodiments, the needle assembly 202 may be removed, and a syringe 802 may be coupled to the housing 204 for flushing the catheter system 100 or for injecting medication, saline, etc. In some embodiments, the connector 128 may be needleless or may be configured to accept a cannula 210.

[0065] 21A-21B and 22A-22B, in some embodiments, cannula 210 may include one or more side holes 700 that, along with an opening 701 at distal tip 714, provide multiple fluid paths through distal tip 714. In some embodiments, side holes 700 may be located near distal tip 714. In some embodiments, side holes 700 and / or openings 701 may be in fluid communication with a lumen of cannula 210, which may extend through cannula 210. In some embodiments, septum 206 (see, e.g., FIG. 2B) may be spaced from side holes 700 in response to cannula 210 extending through septum 206 to avoid blockage of side holes 700.

[0066] In some embodiments, as shown in FIGS. 21A-21B, the side holes 700 may be substantially annular and may be disposed on one or more sides of the cannula 210. In some embodiments, the side holes 700 may be disposed on opposite sides of the cannula 210. In some embodiments, one or more of the side holes 700 may be formed to extend through the sides of the cannula 210 at an angle. In some embodiments, each of the side holes 700 may be substantially uniform or non-uniform relative to one another. In these and other embodiments, the cannula 210 may include any number of side holes 700, and each of the side holes 700 may include any suitable size, shape, and / or orientation.

[0067] 22A-22B, for example, one or more side holes 700 may include a substantially orthogonal shape. In some embodiments, at least one of the side holes 700 may be formed as a slit extending through the side 707 of the cannula 210, together with the distal tip 714, to provide multiple paths of fluid communication between the lumen 704 of the cannula 210 and the external environment.

[0068] 23A , in some embodiments, connector 128 may be coupled to adapter 114, and blood collection set 200 may be coupled to connector 128. In other embodiments, connector 128 may be coupled to the proximal end of extension set 716, for example, as shown in FIG. 23 . In some embodiments, extension set 716 may include extension tubing 718, which may include a distal end integrated into distal luer 720 and / or a proximal end integrated into proximal luer 722. In some embodiments, blood collection set 200 may be coupled to connector 128. Referring now to FIGS. 23B-23C , in some embodiments, the various configurations of blood collection set 200 described with respect to one or more of FIGS. 1-23 may be disposed at the proximal end of extension set 716.

[0069] 24 , in some embodiments, the extension set 716 may be coupled to the proximal end 104 of the catheter adapter 102, and the needle assembly 202 may be coupled to the proximal end of the extension tube 718. In some embodiments, the proximal end of the extension tube 718 may be integrated within the needle assembly 202. In other embodiments, the needle assembly 202 may be removably coupled to the proximal luer 722. In some embodiments, the various configurations of the blood collection set 200 described with respect to one or more of FIGS. 1-23 may be disposed at the proximal end of the extension set 716.

[0070] In some embodiments, the catheter adapter 102 may include an open catheter adapter, which may not include an integrated extension tube. In some embodiments, the extension set 716 may be coupled to the proximal end 104 of the catheter adapter 102. In some embodiments, the needle assembly 202 may be pre-attached to the extension set 716 or may be coupled to the extension set 716 before coupling the extension set 716 to the proximal end 104 of the catheter adapter 102.

[0071] In some embodiments, after placing catheter 112 within the patient's vasculature, blood collection device 306, which may include a blood collection tube, may be coupled to needle assembly 202, and blood may be collected within blood collection device 306. In some embodiments, in response to blood collection device 306 pushing sheath 216 distally toward body 212, sharpened needle 214 may penetrate sheath 216, and sharpened proximal tip 218 of needle assembly 202 may be inserted into blood collection device 306 for blood collection.

[0072] In some embodiments, after blood is collected, the pinch clamp 136 may be engaged to stop fluid flow through the fluid path of the catheter system 100, which may extend from the catheter 112, through the catheter adapter 102, through the extension set 716, and into the needle assembly 202. In some embodiments, after engaging the pinch clamp 136, the needle assembly 202 may be decoupled from the extension set 176 and removed from the catheter system 100. In some embodiments, after removing the needle assembly 202, the proximal end of the extension set 716 may then be coupled to a flushing or infusion device. In some embodiments, after coupling the proximal end of the extension set 716 to the flushing or infusion device, the pinch clamp 136 may be disengaged and the fluid path may be opened, followed by flushing or infusion of the patient's vasculature through the extension set 716 and the catheter adapter 102 coupled to the extension set 716.

[0073] In some embodiments, after flushing or infusion, pinch clamp 136 may be engaged to stop flow through extension set 176, and / or needle assembly 202 may then be coupled to a connector, such as, for example, connector 128 (see one or more of FIGS. 1-20). In some embodiments, connector 128 may be coupled to the proximal end of extension set 176, and / or housing 204 (see, for example, one or more of FIGS. 1-20) may be coupled to connector 128. In these and other embodiments, housing 204 may be uncoupled from connector 128 and removed from catheter system 100 after flushing or infusing through a flushing or infusion device coupled to housing 204.

[0074] All examples and conditional language set forth herein are intended for educational purposes to aid the reader in understanding the present disclosure and concepts provided by the inventors to further the present technology, and should be construed as not being limited to such specifically recited examples and conditions. Although embodiments of the present disclosure have been described in detail, it should be understood that various changes, substitutions, and alterations can be made thereto without departing from the spirit and scope of the present disclosure.

Claims

1. An extension set, the extension set comprising: a catheter adapter including a distal end, a proximal end, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter; a distal end configured to be coupled to the proximal end of the catheter adapter; and Proximal end an extension set including a needle assembly coupled to the proximal end of the extension set, the needle assembly including a body, a sharp needle extending proximally from the body, and a sheath covering a proximal tip of the sharp needle; A system comprising:

2. 10. The system of claim 1, wherein the needle assembly is directly coupled to the proximal end of the extension set.

3. a needleless connector coupled directly to the proximal end of the extension set, the needleless connector including a septum; a housing coupled directly to the needleless connector and the needle assembly, the housing configured to create a fluid pathway through the needleless connector; The system of claim 2 further comprising:

4. a catheter extending distally from the distal end of the catheter adapter; The system of claim 3 further comprising:

5. a needle assembly including a body, a sharpened needle extending proximally from the body, and a sheath covering the proximal tip of the sharpened needle; a housing coupled to a distal end of the needle assembly, the housing configured to create a fluid pathway through a connector; 10. A blood collection set for coupling to a catheter system, further comprising:

6. 6. The blood collection set of claim 5, wherein said housing is directly and removably coupled to said needle assembly.

7. 6. The blood collection set of claim 5, wherein said housing is integral with said needle assembly.

8. 6. The blood collection set of claim 5, wherein the distal end of the housing includes a male luer, the male luer including threads or configured for a slip fit.

9. 6. The blood collection set of claim 5, wherein the housing includes a distal piece and a proximal piece movable distally toward the distal piece, the distal piece of the housing including a male luer configured to actuate a septum of the connector and create the fluid path through the connector in response to the proximal piece moving distally toward the distal piece.

Images