BLOOD COLLECTION ADAPTER AND ASSOCIATED SYSTEMS AND METHODS - Patent application

Abstract

The catheter system may include a catheter adapter having a distal end, a proximal end, and a lumen extending through the distal end of the catheter adapter to the proximal end of the catheter adapter. The catheter system may include a catheter extending distally from the distal end of the catheter adapter. The catheter system may include a connector coupled to the catheter adapter and including a septum. The catheter system may also include a blood collection adapter coupled to the connector. The blood collection adapter may be configured to create a fluid path through the connector. The catheter system may include a blood collection set coupled to the blood collection adapter. The blood collection set may include a needle assembly configured to receive a blood collection container.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of Chinese Patent Application No. 202210027336.1, filed on January 11, 2022, titled "BLOOD COLLECTION ADAPTER AND RELATED SYSTEMS AND METHODS," and U.S. Provisional Patent Application No. 63 / 300,875, filed on January 19, 2022, titled "BLOOD COLLECTION ADAPTER AND RELATED SYSTEMS AND METHODS," the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates generally to blood collection adapters for use with peripheral intravenous catheters ("PIVCs"), and related assemblies, systems, and methods. The adapters are configured to allow blood collection via a PIVC both during catheter placement and while the catheter is indwelling. [Background technology]

[0003] Catheters are generally used to inject fluids into a patient's blood vessels. For example, catheters may be used to inject normal saline solution, various medications, or total parenteral nutrition into a patient.

[0004] The catheter may be a peripheral intravenous ("IV") catheter. In this case, the catheter may be mounted over an introducer needle having a sharp distal tip. The catheter and introducer needle may be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the catheter, with the bevel of the needle pointing away from the patient's skin. The catheter and introducer needle are typically inserted at a shallow angle through the patient's skin and into the vasculature.

[0005] To verify proper placement of the introducer needle and / or catheter within the vasculature, the physician will typically confirm the presence of a "flashback" of blood in a flashback chamber in the catheter assembly. Once placement of the introducer needle within the vasculature has been confirmed, the physician may withdraw the introducer needle, leaving the catheter in place for future fluid injections.

[0006] Blood collection through peripheral venous catheters is not routinely performed, primarily due to the risk of hemolysis when drawing blood samples through peripheral venous catheters. Instead, blood collection is frequently performed with, for example, BD VACUTAINER® ULTRATOUCH™ push-button blood collection sets available from Becton, Dickinson & Company of Franklin Lakes, New Jersey. A common problem when using peripheral venous catheters to draw blood from patients is that red blood cells are subject to high shear stress when blood is drawn into a syringe or BD VACUTAINER® push-button blood collection tube, and are prone to hemolysis due to the high pressure difference between the blood vessel and the syringe or BD VACUTAINER® push-button blood collection tube. Hemolysis can result in rejection and discarding of the blood sample. The high pressure difference can cause catheter tip breakage, blood vessel damage, or other complications.

[0007] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is only provided to illustrate one example technology area in which some implementations described herein may be practiced. Summary of the Invention

[0008] The present disclosure relates generally to blood collection adapters and associated assemblies, systems, and methods. In some embodiments, a catheter system may include a catheter adapter, the catheter adapter 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 system may include a connector coupled to the catheter adapter. In some embodiments, the connector may include a septum.

[0009] In some embodiments, the catheter system may include a blood collection adapter coupled to the connector. In some embodiments, the blood collection adapter may be configured to create a fluid pathway through the connector. In some embodiments, the catheter system may include a blood collection set coupled to the blood collection adapter. In some embodiments, the blood collection set may include a needle assembly configured to receive a blood collection container.

[0010] In some embodiments, the catheter system may include a side port disposed between a distal end of the catheter adapter and a proximal end of the catheter adapter, an extension tube, and an adapter. In some embodiments, the distal end of the extension tube may be integrated with the side port of the catheter adapter, and the proximal end of the extension tube may be integrated with the distal end of the adapter. In some embodiments, the adapter may include a distal end and a port. In some embodiments, a connector may be coupled to the port of the adapter. In some embodiments, the adapter may include a Y adapter.

[0011] In some embodiments, the blood collection adapter may include a distal portion and a proximal portion movable distally toward the distal portion. In some embodiments, the proximal portion may be configured to activate a septum and create a fluid pathway through the connector in response to the proximal portion moving distally toward the distal portion. In some embodiments, the proximal portion of the blood collection adapter may include a cannula configured to be inserted into a septum of the connector to create a fluid pathway through the connector.

[0012] In some embodiments, the needle assembly may include a body, a sharpened needle extending proximally from the body, and a cover covering the proximal tip of the sharpened needle. In some embodiments, the sharpened needle and the cannula may be formed separately and of different sizes. In some embodiments, the sharpened needle and the cannula may be formed separately and of the same size. In some embodiments, the sharpened needle and the cannula may be integrally formed as a single unit. In some embodiments, the blood collection adapter and the body of the needle assembly may be integrally formed as a single unit.

[0013] In some embodiments, the proximal portion of the blood collection adapter may comprise a male luer. In some embodiments, the connector may include a needleless connector. In some embodiments, the distal end of the cannula may comprise a chamfer or a flow diverter.

[0014] In some embodiments, the catheter system may include an extension set having a distal end coupled to a proximal end of the catheter adapter and a proximal end coupled to the connector.

[0015] In some embodiments, a blood collection assembly that couples to the catheter assembly may include a needle assembly and a blood collection adapter coupled to a distal end of the needle assembly. In some embodiments, the blood collection adapter may be configured to create a fluid pathway through the connector. In some embodiments, the blood collection adapter may be directly and movably coupled to the needle assembly. In some embodiments, the blood collection adapter may be integrally formed as a single unit with the body of the needle assembly.

[0016] In some embodiments, the method may include coupling the blood collection assembly to a catheter assembly. In some embodiments, the catheter assembly may include a catheter adapter that 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 assembly may include a catheter and a connector coupled to the catheter adapter. In some embodiments, the connector may include a septum.

[0017] In some embodiments, the method may include moving the proximal portion distally towards the distal portion. In some embodiments, the male luer or cannula may be configured to activate a septum of the connector and create a fluid path through the connector in response to moving the proximal portion distally towards the distal portion. In some embodiments, the method may include collecting blood in a blood collection device coupled to the needle assembly after moving the proximal portion distally towards the distal portion. In some embodiments, the method may include flushing the catheter assembly or injecting fluid through the catheter assembly after disconnecting the blood collection set and moving the needle assembly from the blood collection set.

[0018] In accordance with another embodiment of the present disclosure, a catheter system may be provided that includes a catheter adapter having 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. The catheter system may further include a catheter extending distally from the distal end of the catheter adapter and a connector coupled to the catheter adapter and including a septum. The catheter system may also include a blood collection adapter coupled to the connector, the blood collection adapter including a cannula configured to be inserted into the septum of the connector to create a fluid pathway through the connector.

[0019] In some embodiments, the blood collection adapter comprises a body and at least two opposing lever arms coupled to the body via respective flex points, and further, the at least two opposing lever arms may be configured to releasably couple the blood collection adapter to the connector.

[0020] In some embodiments, the blood collection adapter may further include an adapter hub coupled to the body, and the adapter hub may include an inner body portion that surrounds a portion of the cannula.

[0021] In some embodiments, the adapter hub may further comprise a proximal connection portion configured to connect the blood collection adapter to a Luer lock access device.

[0022] In some embodiments, the luer lock access device may include a luer lock hub having internal threads that can engage an adapter hub, a needle, and a proximal coupling portion of a sheath surrounding the needle.

[0023] In some embodiments, the luer lock access device may further comprise a holder configured to hold a blood collection device.

[0024] In some embodiments, the luer lock access device may further comprise a protective cover at least partially surrounding the needle and the shroud.

[0025] In some embodiments, the cannula may include a beveled tip.

[0026] In some embodiments, the beveled tip of the cannula is configured to extend only into a proximal portion of the interior passageway of the connector after the cannula is inserted into the septum.

[0027] In some embodiments, the cannula may include at least one side hole.

[0028] In some embodiments, at least one side hole of the cannula is configured to extend only into a proximal portion of the interior passageway of the connector after the cannula is inserted into the septum.

[0029] In accordance with another embodiment of the present disclosure, a catheter system may be provided that includes a catheter adapter having 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. The catheter system may further include a catheter extending distally from the distal end of the catheter adapter and a needleless connector coupled to the catheter adapter and having a septum. The catheter system may include a blood collection adapter coupled to the needleless connector, the blood collection adapter having blunt tips extending from their distal ends and including a central portion configured to be inserted into the septum of the needleless connector to create a fluid pathway through the needleless connector.

[0030] In some embodiments, the blood collection adapter may include at least one side hole located adjacent the blunt tip.

[0031] In some embodiments, the at least one side hole is configured to extend only into a proximal portion of the internal passage of the needleless connector after the blunt tip is inserted into the septum.

[0032] In some embodiments, the blood collection adapter may further include an adapter hub coupled to the holder portion, and the adapter hub may include an inner body portion that surrounds a portion of the cannula.

[0033] In some embodiments, the cannula extends between the adapter hub and the blunt tip to form a fluid pathway therebetween.

[0034] In some embodiments, the adapter hub may further comprise a proximal connection portion configured to connect the blood collection adapter to a Luer lock access device.

[0035] In some embodiments, the luer lock access device may further comprise a luer lock hub having internal threads capable of engaging the adapter hub, the needle, and a proximal coupling portion of the sheath surrounding the needle.

[0036] In some embodiments, the luer lock access device may further comprise a holder configured to hold a blood collection device.

[0037] It is to be understood that both the following general description and the detailed description are exemplary and illustrative and are not intended to limit the present invention, as claimed. It is to be understood that the various embodiments are not limited in the arrangement and instrumentality as shown in the drawings. It is to be understood that the embodiments may be combined or utilized in different ways, and structural changes may be made, unless otherwise claimed, without departing from the scope of the various embodiments of the present invention. Therefore, the following detailed description is not to be construed as limiting.

[0038] Exemplary embodiments will be detailed and explained through the use of additional details and drawings. [Brief description of the drawings]

[0039] [Figure 1A] FIG. 1A is a top perspective view of an exemplary catheter system with hemolysis protection showing an exemplary blood collection adapter in a proximal position, according to some embodiments. [Figure 1B] FIG. 1B is a top perspective view of the catheter system showing the blood collection adapter in a distal position, according to some embodiments. [Figure 1C] FIG. 1C is a cross-sectional view of a portion of the catheter system showing a blood collection adapter in a proximal position, according to some embodiments. [Figure 1D] FIG. 1D is an expanded view of a portion of the catheter system, according to some embodiments. [Figure 1E] FIG. 1E is a cross-sectional view of a portion of a catheter system showing a blood collection adapter in a distal position, according to some embodiments. [Figure 1F] FIG. IF is a cross-sectional view of a portion of a catheter system showing a blood collection adapter, according to some embodiments. [Figure 1G] FIG. 1G is a cross-sectional view of a portion of a catheter system, according to some embodiments. [Figure 2A] FIG. 2A is a top perspective view of a catheter system with hemolysis protection showing another exemplary blood collection adapter in a proximal position, according to some embodiments. [Figure 2B] FIG. 2B is a cross-sectional view of the catheter system showing the other blood collection adapter in a proximal position, according to some embodiments. [Figure 2C] FIG. 2C is an expanded view of a portion of the catheter system, according to some embodiments. [Figure 2D] FIG. 2D is a cross-sectional view of a portion of the catheter system showing the other blood collection adapter in a distal position, according to some embodiments. [Figure 2E] FIG. 2E is a cross-sectional view of a portion of a catheter system showing an exemplary male luer, according to some embodiments. [Figure 2F] FIG. 2F is a cross-sectional view of the distal end of an exemplary male luer, according to some embodiments. [Figure 3A] FIG. 3A is a bar glove showing the use of a blood collection adapter, according to some embodiments. [Figure 3B] FIG. 3B is a bar glove showing the use of the other blood collection adapter, according to some embodiments. [Figure 3C] FIG. 3C is a bar glove illustrating the use of another blood collection adapter, according to some embodiments. [Figure 4A] FIG. 4A is a top perspective view of an exemplary catheter system with a syringe, according to some embodiments. [Figure 4B] FIG. 4B is a stick diagram showing the use of a syringe, according to some embodiments. [Figure 5A] FIG. 5A is a side view of a blood collection adapter according to another embodiment of the present disclosure. [Figure 5B] FIG. 5B is a cross-sectional view of the blood collection adapter of FIG. 5A coupled to a connector according to an embodiment of the present disclosure. [Figure 6A] FIG. 6A is a side view of the blood collection adapter of FIG. 5A coupled to a connector and a luer lock access device according to an embodiment of the present disclosure. [Figure 6B] 6B is a cross-sectional view of the blood collection adapter, connector, and luer lock access device of FIG. 6A. [Figure 7A] FIG. 7A is a side view of a luer lock access device, according to some embodiments. [Figure 7B] FIG. 7B is a side view of another luer lock access device, according to some embodiments. [Figure 7C] FIG. 7C is a side view of another luer lock access device, according to some embodiments. [Figure 8A]FIG. 8A is a cross-sectional view of a blood collection adapter and connector according to another embodiment of the present disclosure. [Figure 8B] FIG. 8B is a side view of the cannula of the blood collection adapter of FIG. 8A. [Figure 8C] 8C is a cross-sectional view of a portion of the connector and cannula of the blood collection adapter of FIG. 8A. [Figure 9A] FIG. 9A is a top view of a catheter system according to another embodiment of the present disclosure. [Figure 9B] FIG. 9B is a side view of a blood collection adapter, connector, and luer lock access device according to another embodiment of the present disclosure. [Figure 9C] FIG. 9C is a top view of the catheter system of FIG. 9A having a blood collection adapter, a connector, a Luer lock access device and a blood collection container coupled thereto in accordance with another embodiment of the present disclosure. [Figure 9D] FIG. 9D is a top view of the catheter system of FIG. 9A having a blood collection adapter, a connector, and a syringe coupled thereto, according to another embodiment of the present disclosure. [Figure 9E] FIG. 9E is a top view of a catheter system according to an embodiment of the present disclosure. [Figure 9F] FIG. 9F is a perspective view of the blood collection adapter of FIG. 9B according to an embodiment of the present disclosure. [Figure 10A] FIG. 10A is a cross-sectional view of a blood collection adapter, connector, and luer lock access device in a first position according to another embodiment of the present disclosure. [Figure 10B] FIG. 10B is a cross-sectional view of a blood collection adapter, connector, and luer lock access device in a second position according to another embodiment of the present disclosure. [Figure 11A] FIG. 11A is a perspective view of a blood collection adapter according to another embodiment of the present disclosure. [Figure 11B] FIG. 11B is a cross-sectional view of the blood collection adapter of FIG. 11A. [Figure 12A]FIG. 12A is a perspective view of the blood collection adapter of FIG. 11A coupled to a Luer lock access device according to another embodiment of the present disclosure. [Figure 12B] 12B is a cross-sectional view of the blood collection adapter of FIG. 11A coupled to a luer lock access device and needleless connector according to another embodiment of the present disclosure. [Figure 12C] FIG. 12C is a cross-sectional view of a portion of the blood collection adapter of FIG. 11A coupled to a needleless connector. [Figure 13] FIG. 13 is a cross-sectional view of a blood collection adapter and a portion of a needleless connector according to another embodiment of the present disclosure. [Figure 14A] FIG. 14A is a top view of a catheter system according to another embodiment of the present disclosure. [Figure 14B] FIG. 14B is a side view of a blood collection adapter and a luer lock access device according to an embodiment of the present disclosure. [Figure 14C] FIG. 14C is a top view of the catheter system of FIG. 14A having a blood collection adapter, a connector and a Luer lock access device coupled thereto, according to another embodiment of the present disclosure. [Figure 14D] FIG. 14D is a top view of the catheter system of FIG. 14A having a blood collection adapter, connector, Luer lock access device and a blood collection container coupled thereto, according to another embodiment of the present disclosure. [Figure 14E] FIG. 14E is a top view of the catheter system of FIG. 14A having a blood collection adapter, a connector, and a syringe coupled thereto, according to another embodiment of the present disclosure. [Figure 14F] FIG. 14F is a top view of a catheter system according to an embodiment of the present disclosure. [Figure 14G] FIG. 14G is a perspective view of the blood collection adapter of FIG. 14B according to an embodiment of the present disclosure. [Figure 15A] FIG. 15A is a cross-sectional view of a blood collection adapter, connector, and luer lock access device in a first position according to another embodiment of the present disclosure. [Figure 15B] FIG. 15B is a cross-sectional view of a blood collection adapter, connector, and luer lock access device in a second position according to another embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0040] 1A-1B , according to some embodiments, a catheter system 100 may include a catheter adapter 102, which 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. In some embodiments, the catheter 112 may include a peripheral venous catheter, a peripherally inserted central catheter, a midline catheter, or another suitable catheter.

[0041] In some embodiments, the catheter assembly of the catheter system 100 may comprise or correspond to any suitable catheter assembly, 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 catheter assembly.

[0042] 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 distal ends 116, a first port 118, and a second port 120. In some embodiments, an extension tube 122 may be integral with the adapter 114 and / or a portion of the catheter adapter 102, such as, for example, the side port 110. In some embodiments, in response to the catheter 112 being inserted into a patient's vein, blood may flow through the catheter 112, at least a portion of the catheter adapter 102, the extension tube 122, and the adapter 114.

[0043] In some embodiments, the catheter system 100 may include an extension tube 122, which may have a distal end 124 integrated with the side port 110 and / or 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 128 or another suitable clamp, may be disposed on the extension tube 122 and configured to selectively tighten the extension tube 122 to close a fluid path through the extension tube 122. In some embodiments, the pinch clamp 128 may be replaced with any suitable clamp.

[0044] In some embodiments, the first port 118 and / or the second port 120 of the adapter 114 may be coupled to the connector 130. In further detail, in some embodiments, the connector 130 may be integrally formed with the first port 118 and / or the second port 120 as a single unit. In other embodiments, the first port 118 and / or the second port 120 of the adapter 114 may be coupled to the connector 130 via a luer connector. In these embodiments, the connector 130 may comprise a luer, such as, for example, a female or male luer. In some embodiments, the luer may be threaded or slip-fit ​​with the adapter 114. In some embodiments, the connector 130 may be pre-attached to the adapter 114 during manufacturing or assembly.

[0045] In some embodiments, the catheter 112 may comprise an indwelling needle catheter such that the introducer needle 132 extends from the needle hub 134, through the catheter 112, and into the vasculature of the patient for inserting the catheter system 100. 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 and introducer needle 132 may be assembled such that the sharpened distal tip of the introducer needle 132 extends beyond the distal tip of the introducer needle 132 and the bevel of the introducer needle 132 points away from the patient's skin.

[0046] In some embodiments, the introducer needle 132 and catheter 112 are inserted at a shallow angle through the patient's skin and into the patient's vascular system. 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 within the needle hub 134, indicating to the user that the introducer needle 132 is within the patient's vascular system.

[0047] In some embodiments, the connector 130 may be coupled to a blood collection adapter 136. In some embodiments, the blood collection adapter 136 may include a proximal end configured to receive a blood collection set 200. Some embodiments of the blood collection set 200 may include a needle assembly 202 and may be configured to engage with the blood collection adapter 136. In some embodiments, the blood collection set 200 may be used for one or more of collection, irrigation, and infusion of blood from a patient.

[0048] In some embodiments, the proximal end of the connector 130 may include a septum 131, which may be coupled to the body of the connector 130. In some embodiments, the blood collection adapter 136 may include a cannula 138 configured to be inserted into or extend through the septum 131 to provide a fluid path through the connector 130. In these and other embodiments, the tip of the cannula 138 may be disposed within the blood collection adapter 136 to reduce the risk of injury to the user. In some embodiments, the tip of the cannula 138 may be blunt, to reduce the risk of injury to the connector 130, or may be sharp to facilitate insertion of the septum 131. In some embodiments, the cannula 138 may extend distally from the blood collection adapter 136, and the proximal end of the cannula 138 may be secured within the blood collection adapter 136 via a press fit, adhesive, a mechanical device, or another suitable mechanism. In some embodiments, the cannula 138 may include a notch between the tip of the cannula 138 and the proximal end of the cannula. In some embodiments, the notch may provide access to the lumen of the cannula 138 and facilitate cleaning after blood collection.

[0049] In some embodiments, cannula 138 may be constructed from metal or another suitable material. In some embodiments, the outer diameter of cannula 138 may be uniform along all or a portion of the length of cannula 138. In some embodiments, the portion of blood collection adapter 136 that extends from cannula 138 may be constructed from plastic or another suitable material. All or a portion of blood collection adapter 136 may be constructed from plastic or another suitable material.

[0050] In some embodiments, the needle assembly 202 of the blood collection set 200 may include a body 212, a sharpened needle 214 extending proximally from the body 212, and a cover 216 covering a sharpened proximal tip 218 of the sharpened needle 214. In some embodiments, the cover 216 may be elastomeric. In some embodiments, the cover 216 may be plastic or another suitable material. In some embodiments, the sharpened needle 214 may be secured within the body 212 via a press fit, adhesive, a mechanical device, or another suitable mechanism. In some embodiments, the sharpened needle 214 may extend proximally beyond the body 212.

[0051] In some embodiments, the sheath 216 may be coupled to the body 212 of the needle assembly 202. In some embodiments, the sharpened proximal tip 218 of the sharpened needle 214 may be encased within the sheath 216. In some embodiments, the sheath 216 may comprise an open distal end and a closed proximal end. In some embodiments, the body 212 may comprise a luer, which may be coupled to a corresponding luer on the proximal end of the blood collection adapter 136.

[0052] As shown in FIG. 1A, in some embodiments, the blood collection adapter 136 may be coupled to the connector 130 at a proximal location where the tip of the cannula 138 is proximally adjacent to or in contact with the connector 130 without passing through or piercing the connector 130 or septum 131. In these and other embodiments, the distal tip 140 may be proximal to the septum 131. In this manner, some embodiments of the catheter system 100 may reduce the risk of leakage by maintaining a closed fluid path during the shelf life of the catheter system 100. In some embodiments, the blood collection adapter 136 may be pre-attached to the connector 130 at a proximal location during manufacture or assembly. In other embodiments, the blood collection adapter 136 may be pre-attached to the connector 130 during manufacture or assembly with the cannula 138 extending through the septum 131 of the connector 130.

[0053] In some embodiments, blood collection adapter 136 may be movable from a proximal position to a distal position, for example, as shown in FIG. 1B. In some embodiments, in response to blood collection adapter 136 being in the distal position, a fluid path through septum 131 may be open. In some embodiments, a user may move blood collection adapter 136 from a proximal position to a distal position to push cannula 138 into and / or through septum 131, for example, prior to blood collection.

[0054] In some embodiments, blood collection set 200 may be configured to receive a blood collection tube or blood collection device 222, such as, for example, a BD VACUTAINER® blood collection tube. In some embodiments, in response to blood collection device 222 pushing sheath 216 distally toward body 212, sharpened needle 214 pierces the sheath and sharpened proximal tip 218 of needle assembly 202 may be inserted into blood collection device 222 when blood collection adapter 136 is in a distal position.

[0055] In some embodiments, inserting the sharpened proximal tip 218 into the blood collection device 222 may couple the blood collection device 222 to the blood collection set 200. In some embodiments, the blood collection device 222 may be coupled to the blood collection set 200 after the catheter 112 is placed in the vasculature and / or the blood collection adapter 136 is moved to a distal position. In some embodiments, when the blood collection device 222 is inserted by the sharpened proximal tip 218, blood may flow into the blood collection device 222 due to a pressure difference between the vasculature and the blood collection device 222. In some embodiments, the needle assembly 202 may include a thread 224, which may be coupled to a corresponding thread of a cylindrical holder (not shown) for the blood collection device 222.

[0056] 1C, blood collection set 200 and blood collection adapter 136 are shown coupled to connector 130 and in a proximal position, according to some embodiments. In some embodiments, the proximal end of connector 130 may include a septum 131, which may be coupled to body 140 of connector 130. In some embodiments, body 142 may be rigid or semi-rigid. In some embodiments, septum 131 may be comprised of an elastomeric and / or resilient material. In these and other embodiments, septum 131 may or may not include a slit. In some embodiments, the distal end of connector 130 may include a luer 144.

[0057] In some embodiments, the distal tip 140 of the cannula 138 may be enclosed by the blood collection adapter 136 to improve safety for the user. In some embodiments, the blood collection adapter 136 may include two or more lever arms 146 that may be opposed to one another and each coupled to the body 148 of the blood collection adapter 136 at a flex point 150. In some embodiments, a hook member 152 disposed at the distal end of each of the lever arms 146 may be configured to be disposed within a groove 154 of the connector 130 when the lever arms 146 are in a relaxed position, as shown, for example, in FIG. 1C. In some embodiments, the groove 154 may be annular, or the connector 130 may include another groove.

[0058] In some embodiments, the proximal end of each of the lever arms 146 proximal to the flex point 150 may be pushed inwardly to bias the distal end of the lever arm 146 outwardly and release the hook member 152 of the lever arm 146 from the groove 154. In some embodiments, the distal end of each of the lever arms 146 may automatically return to the relaxed position from the biased position in response to the proximal end of the lever arm 146 being released or not pushed inwardly.

[0059] In some embodiments, blood collection adapter 136 may include one or more fingers 151 that may be bent or positioned to be biased outward to fit over connector 130. In some embodiments, fingers 151 may extend distally from cylindrical portion 156 of body 148. In some embodiments, distal tip 140 of cannula 138 may be positioned within cylindrical portion 156 to prevent accidental needle stick injury.

[0060] In some embodiments, blood collection adapter 136 and body 212 may be removably coupled together or separately and may be separate. In these and other embodiments, blood collection set 200 may be used for blood collection via needle assembly 202 and for injection after removal of needle assembly 202 from blood collection adapter 136. Referring now to FIG. 1F, blood collection adapter 136 and body 212 of needle assembly 202 may be integrated or integrally formed as a single unit.

[0061] Referring back to FIG. 1C, in some embodiments, the blood collection set 200 may include a cover 226, which may be removably coupled to a particular blood collection container.

[0062] The overall length of cannula 138 may be represented by L, and the inner diameter of cannula 138 may be represented by D. In some embodiments, the inner diameter of cannula 138 may be the same as and / or larger than the minimum inner diameter of catheter 112 (see, e.g., FIGS. 1A-1B). In some embodiments, D 4 / L is equal to or less than the predetermined value to reduce the maximum shear force. 4 The default value for / L may be:

[0063] [Table 1]

[0064] In the above table, "21G UT" and "25G UT" refer to a 21-gauge BD VACUTAINER® ULTRATOUCH™ push button blood collection set and a 25-gauge BD VACUTAINER® ULTRATOUCH™ push button blood collection set, respectively. "Gauge" corresponds to the gauge of the catheter of the catheter assembly, such as catheter 112 of FIGS. 1A-1B.

[0065] Referring now to FIG. 1D, there is shown a close-up view of the connector 130, blood collection adapter 136, and blood collection set 200, according to some embodiments.

[0066] 1E, blood collection set 200 and blood collection adapter 136 in a distal position, according to some embodiments. In some embodiments, in response to blood collection adapter 136 moving from a proximal position to a distal position, cannula 138 may be inserted or extended through septum 131 to provide a fluid path through connector 130.

[0067] 1F, in some embodiments, blood collection adapter 136 and body 212 of blood collection set 200 may be integrally formed as a single unit, which may reduce the risk of the distal tip 140 of cannula 138 accidentally pricking a user. Now referring to FIG. 1G, in some embodiments, cannula 138 may extend proximally to sharpened needle 214. In these embodiments, cannula 138 and sharpened needle 214 may be integrally formed as a single unit or combined together. In these embodiments, D corresponds to the inner diameter of cannula 138 and may be constant. In some embodiments, L may correspond to the length of cannula 138 or the combined length of cannula 138 and sharpened needle 21. In some embodiments, the length of the cannula 138 may extend from the distal tip 140 of the cannula 138 to or near the distal end 155 of the internal cavity.

[0068] In some embodiments, D 4 The default value for / L may be:

[0069] [Table 2]

[0070] "21G UT" and "25G UT" refer to BD VACUTAINER® ULTRATOUCH™ push button blood collection sets for use with 21-G and 25-G catheters, respectively. BD VACUTAINER® ULTRATOUCH™ push button blood collection sets are available from Becton, Dickinson & Company of Franklin Lakes, New Jersey. "Gauge" corresponds to the gauge of the catheter of the catheter assembly, such as catheter 112 of FIGS. 1A-1B.

[0071] 2A-2D, in some embodiments, blood collection adapter 157 may include a distal portion 158 and a proximal portion 160 that is distally movable toward distal portion 158. In some embodiments, blood collection adapter 157 may be similar or identical to blood collection adapter 136 in terms of one or more functions and / or operations.

[0072] In some embodiments, the proximal portion 160 of the blood collection adapter 157 may comprise a male luer, which may comprise an insert portion 162 and / or a surrounding collar. As shown, for example, in FIG. 2D , in some embodiments, the proximal portion 160 may be moved distally toward the distal portion 158. In some embodiments, the insert portion 162 may open or activate a septum 131 and create a fluid path through the connector 130 in response to the proximal portion 160 moving distally toward the distal portion 158. In some embodiments, the insert portion 162 may extend through the septum 131 in response to the proximal portion 160 moving distally toward the distal portion 158.

[0073] In some embodiments, the connector 130 may include a needleless connector. In some embodiments, the connector 130 may comprise, 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 insert portion 162 may be integrally formed with a collar portion male luer, which may comprise threads or may be configured for a slip fit.

[0074] In some embodiments, the outer surface of the distal portion 158 may include one or more protrusions 164 that may facilitate securing the proximal portion 160 at a proximal location, e.g., as shown in FIG. 2B, and / or at a distal location, e.g., as shown in FIG. 2D. In some embodiments, the inner surface of the blood collection adapter 157 may include one or more additional protrusions 166 across in front of the protrusions 164 and configured to engage the proximal portion 160 in a snap-fit ​​with the distal portion 158. In some embodiments, the additional protrusions 166 may be disposed on the inner surface of one or more arms 168 of the proximal portion 160 of the blood collection adapter 157, which may be bent apart from the remainder of the proximal portion 160 along opposing edges and ends of the arms 221.

[0075] In these embodiments, D may correspond to the inner diameter of insert portion 162, which may be constant. In some embodiments, L may correspond to the length of insert portion 162, which may extend from base 223, from which arm 168 may extend.

[0076] In some embodiments, D 4 The default value for / L may be:

[0077] [Table 3]

[0078] "21G UT" and "25G UT" refer to BD VACUTAINER® ULTRATOUCH™ push button blood collection sets for use with 21-G and 25-G catheters, respectively. BD VACUTAINER® ULTRATOUCH™ push button blood collection sets are available from Becton, Dickinson & Company of Franklin Lakes, New Jersey. "Gauge" corresponds to the gauge of the catheter of the catheter assembly, such as catheter 112 of FIG. 2A.

[0079] 2E, in some embodiments, the distal end of the insert portion 162 may include one or more chamfers 170 to facilitate cleaning after blood collection. Now referring to FIG. 2F, in some, the distal end of the insert portion 162 may include one or more flow diverters 172. For example, the distal end of the insert portion 162 may include a flow diverter 172 that extends into the lumen of the insert portion 162. In some embodiments, the flow diverter may be configured to allow fluid to flow to a peripheral circumferential dead space located distal to the distal end of the insert portion 162.

[0080] 3A, in some embodiments, blood collection adapter 136 and blood collection adapter 157 may provide hemolysis protection, as described with respect to FIGS. 1C and 2E. In further detail, blood collection adapter 136 and blood collection adapter 157 may limit the maximum blood collection rate during blood collection, which in turn may limit the maximum shear force and reduce hemolysis. In some embodiments, blood collection adapter 136 and blood collection adapter 157 may be configured to limit the maximum shear force to which blood cells are exposed during blood collection to a predetermined or target value. In some embodiments, a fluid path extending through blood collection adapter 136 or blood collection adapter 157 may help reduce the maximum shear force to an acceptable level, reducing the possibility of mechanical hemolysis.

[0081] "UT" on the x-axis of FIG. 3A refers to a conventional blood collection set, i.e., a BD VACUTAINER® ULTRATOUCH™ push button blood collection set. "Intima II" on the x-axis of FIG. 3B refers to a BD INTIMA II™ IV catheter, a conventional catheter assembly used for blood collection without a blood collection adapter 136. "Blood collection adapter 136" refers to the blood collection adapter 136 described with respect to FIGS. 1A-1F or a similar blood collection adapter used with a pre-needle ("PRN") type connector. "Blood collection adapter 157" refers to the blood collection adapter 157 described with respect to FIGS. 2A-2F or a similar adapter used with a needleless connector. "21G UT" refers to a 21G BD VACUTAINER® ULTRATOUCH™ push button blood collection set. FIG. 3A shows that blood collection adapter 136 or blood collection adapter 157 may reduce the maximum shear force to the same amount as a 25G BD VACUTAINER® ULTRATOUCH™ push button blood collection set.

[0082] Referring now to FIG. 3B, "UT" on the x-axis of FIG. 3B refers to a conventional blood collection set, i.e., a BD VACUTAINER® ULTRATOUCH™ push button blood collection set. "Intima II" on the x-axis of FIG. 3B refers to a conventional catheter assembly, the BD INTIMA II™ IV catheter, used for blood collection without blood collection adapter 136 or blood collection adapter 156. "BD INTIMA II 21G UT" on the x-axis of FIG. 3B refers to a BD INTIMA II™ IV catheter with a fluid path compatible with "21G UT." "BD INTIMA II 25G UT" on the x-axis of FIG. 3B refers to a BD INTIMA II™ IV catheter with a fluid path compatible with "25G UT." Blood collection adapter 136 is used with an "INTIMA II 25G UT" and blood collection adapter 157 is used with an "INTIMA II 21G UT". 18G, 20G, 22G or 24G corresponds to the gauge of the catheter of the catheter assembly that is coupled to blood collection adapter 136 or blood collection adapter 157. FIG. 3B shows that the use of blood collection adapter 157 and blood collection adapter 136 may reduce the maximum shear force to the same amount as a 25G BD VACUTAINER® ULTRATOUCH™ push button blood collection set.

[0083] 3C, the fluid path dimensions (see, e.g., FIGS. 1A-1G) of the blood collection adapter 136 may be selected to accommodate a maximum shear force with a 21G BD VACUTAINER® ULTRATOUCH™ push button blood collection set. In FIG. 3C, "IAG" on the x-axis of FIG. 3C refers to the BD INSYTE™ AUTOGUARD™ BC Shielded IV Catheter (available from Becton, Dickinson & Company of Franklin Lakes, New Jersey). Similar results are expected for the INTIMA II™ (BD INTIMA II™ IV Catheter available from Becton, Dickinson & Company of Franklin Lakes, New Jersey) since the extension tube has less effect on the fluid resistance. D may correspond to the inner diameter of the cannula 138, which may be the same as the inner diameter of the sharp needle 214. L may correspond to the combined length of the cannula 138 and the sharp needle 214. In this case, the blood collection adapter 136 may increase the blood collection rate while still fully accommodating the maximum shear force of a 21G or 25G "UT" (BD VACUTAINER® ULTRATOUCH™ push button blood collection set). In some embodiments, as shown in FIG. 3C, blood collection rates can be significantly increased for 20G and 18G catheters while still fully accommodating the maximum shear force of a 21G BD VACUTAINER® ULTRATOUCH™ push button blood collection set.

[0084] 3C discloses an embodiment in which the inner diameter of the cannula 138 and the inner diameter of the sharp needle 214 are the same, in accordance with other embodiments of the present invention, the gauge (and therefore inner diameter) of the cannula 138 and the gauge (and therefore inner diameter) of the sharp needle 214 may be different and specifically selected to optimize blood collection rate and reduction of hemolysis for blood collection through a particular catheter assembly. For example, see the table below, various gauge combinations for the cannula 138 and sharp needle 214 are selected based on the gauge of the catheter assembly and the resulting combined hydraulic resistance of the cannula 138 and sharp needle 214.

[0085] [Table 4]

[0086] As discussed above, the 18G, 20G, 22G, or 24G corresponds to the gauge of the catheter assembly coupled to the blood collection adapter 136. The type and size of the cannula 138 and the gauge of the sharp needle 214 of the blood collection adapter 136, respectively, may be selected based on the gauge of the catheter assembly, and the cannula and / or sharp needle may be selected to optimize volumetric flow rate while accounting for acceptable shear-induced hemolysis of the blood sample. Such determinations may be made by any suitable method, such as computational fluid dynamics (CFD) simulations, bench testing, etc.

[0087] For both the 18G and 20G catheter assemblies, as shown in the above example, it was determined that optimization of flow and hemolysis conditions was possible by having the same gauge cannula 138 and sharp needle 214. However, for the 22G and / or 24G catheter assemblies, optimization of flow and hemolysis conditions was possible by varying the hydraulic resistance of the combination of a cannula 138 and sharp needle 214 having a different gauge. The above example shows only one embodiment, and different gauges and / or dimensions (and therefore different combined hydraulic resistances) may be selected for other catheter assemblies.

[0088] Additionally, although not shown in the table above, the length of the cannula 138 may be selected based on the determined hemolysis potential and blood collection rate of the blood sample. Additionally and / or alternatively, the cannula 138 and / or the sharp needle 214 may be selected to have different wall thicknesses to further reduce the hemolysis potential and blood collection rate. For example, both the cannula 138 and the sharp needle 214 may have normal wall (or [RW]) or thin wall (or [TW]) thicknesses, with the thickness of the cannula determining the inner diameter of the cannula and thus varying the hemolysis potential and / or blood collection rate.

[0089] 4A, in some embodiments, the catheter system 100 may include a syringe 250, which may include a distal end 252 and a proximal end 254. In some embodiments, the syringe 250 may include a slidable plunger 256 that fits tightly into a barrel or tube 258. In some embodiments, the slidable plunger 256 may be pulled proximally relative to the tube 258, causing the syringe 250 to draw liquid, such as blood, through an opening in the distal end 252. In some embodiments, the slidable plunger 256 may be pushed distally relative to the distal end 252, causing the liquid to be subsequently expelled through the opening. In some embodiments, the syringe 250 may be coupled to a proximal end of a blood collection adapter, such as a blood collection adapter 136, which may include a luer 262, or a female luer, or a particular blood collection adapter, such as a blood collection adapter 157. The blood collection adapter 136, according to some embodiments, is shown in a distal position.

[0090] Now referring to FIG. 4B, for a 20G catheter, the risk of hemolysis is moderate at slow syringe pull rates, but increases at fast pull rates. 4 The blood collection adapter with reduced the maximum shear force on catheter withdrawal to that of the 21G UT (BD VACUTAINER® ULTRATOUCH™ Push Button Blood Collection Set with 21G catheter) for all syringe withdrawal speeds tested. For the 22G catheter, the risk of hemolysis is significant at fast withdrawal speeds. A D of D / 7e-8 4The blood collection adapter with reduced the maximum shear force to the absolute benchmark for maximum shear force (BD VACUTAINER® ULTRATOUCH™ push button blood collection set with 21 G catheter) for all syringe withdrawal speeds tested. For a 24 G catheter, the two blood collection adapters mentioned above can reduce the maximum shear force by 2.5-3 times depending on the syringe withdrawal speed. The effect achieved on maximum shear force according to some embodiments is shown in FIG. 4B.

[0091] As described above, after blood collection, it is preferable to flush the adapter 114 and / or the connector 130, for example with saline, to remove any residual blood remaining therein. However, conventional blood collection techniques via indwelling catheters often use an extension needle cannula fluidly connected to an extension set, the extension needle cannula configured to pierce the septum 131 to fluidly connect the extension set to the connector 130. The distal tip of such an extension needle cannula typically extends far into the inner diameter of the connector 130, leaving a significant amount of "dead space" within the connector 130 at a location proximal to the distal tip of the needle cannula. Such flushing of residual blood remaining within the connector 130 using such a configuration is often insufficient, since the dead space within the connector 130 is not fully accessed by flushing fluid expelled from the distal tip of the needle cannula. Furthermore, such extension needle cannula may increase the likelihood of needlestick injury to the caregiver and / or the patient.

[0092] Thus, in accordance with another embodiment of the present disclosure, and with reference to FIGS. 5A and 5B, a blood collection adapter 300 is disclosed that is configured to improve cleaning and reduce the possibility of needle stick injuries.

[0093] 5B, a connector 330 may be coupled to the blood collection adapter 300. It is understood that the connector 330 may be substantially similar to the connector 130 described above. Additionally, as described below, the blood collection adapter 300 may include a proximal end configured to receive a blood collection set. In some embodiments, the blood collection set may be used for one or more of blood collection, irrigation, and infusion from a patient.

[0094] In some embodiments, the proximal end of the connector 330 may include a septum 331, which may be coupled to the body of the connector 330. The blood collection adapter 300 may include a cannula 338 configured to be inserted into or extend through the septum 331 to provide a fluid path through the connector 330. In these and other embodiments, the tip 340 of the cannula 338 may be disposed within the blood collection adapter 300, which may reduce the risk of needlestick injury to the user. In some embodiments, the tip 340 of the cannula 338 may be blunt, reducing the risk of injury, or may be sharp to facilitate insertion of the septum 131. In some embodiments, the cannula 338 extends distally from the blood collection adapter 300, and the proximal end of the cannula 338 may be secured within the blood collection adapter 300 via a press fit, adhesive, a mechanical device, or another suitable mechanism. 5A and 5B, the cannula 338 may be secured to an adapter hub 360 having an inner body portion 335 that surrounds a portion of the cannula 338 and a proximal coupling portion configured to secure the adapter hub 360 to, for example, a Luer lock access device. While FIGS. 5A and 5B are shown as separate components, in some embodiments, the adapter hub 360 may be formed integrally with the blood collection adapter 300.

[0095] In some embodiments, the portion of blood collection adapter 300 from which cannula 338 extends may be constructed from plastic or another suitable material. In some embodiments, all or a portion of blood collection adapter 300 may be constructed from plastic or another suitable material.

[0096] As shown in FIGURE 5B, septum 331 of connector 330 is coupled to body 342 of connector 330. In some embodiments, body 342 may be rigid or semi-rigid. In some embodiments, septum 331 may be comprised of an elastomeric and / or resilient material. In these and other embodiments, septum 331 may or may not include a central slit. In some embodiments, the distal end of connector 130 may include a luer connector, similar to connector 130 described above.

[0097] In some embodiments, a distal tip 340 of cannula 338 may be enclosed by blood collection adapter 300 to improve safety for the user. Additionally, blood collection adapter 300 may include two or more lever arms 346, which may be opposed to one another and each coupled to a body 348 of blood collection adapter 300 via a flex point 350. In some embodiments, a hook member similar to hook member 152 described above with respect to adapter 136 may be disposed at the distal end of each of lever arms 346 to engage groove 154 of connector 330 when lever arm 146 is in the relaxed position, thereby releasably coupling blood collection adapter 300 to connector 330.

[0098] In some embodiments, a proximal end of each lever arm 346 proximal to flex point 350 may be pushed inwardly to bias a distal end of lever arm 346 outwardly and release the hook member of lever arm 346 from connector 330. In some embodiments, the distal end of each lever arm 346 may automatically return from the biased position to a relaxed position in response to the proximal end of lever arm 346 being released or not pushed inwardly.

[0099] 5A, blood collection adapter 300 may include one or more side members 351 and may be configured to fit over and / or at least partially around connector 330. In some embodiments, one or more side members 351 may be flexible and / or resilient to accommodate septum 331. In some embodiments, one or more side members 351 may extend distally from body 348 of blood collection adapter 300 to at least partially slide distal tip 340 of cannula 338 thereover to help prevent accidental needle stick injuries.

[0100] 5B, cannula 338 is shown in a fully distal position relative to connector 330, where distal tip 340 extends through or pierces septum 331 and is in fluid communication with internal passageway 352 of connector 330. However, distal tip 340 of cannula 338 is substantially limited in the distance within internal passageway 352 that it can travel therethrough by the interface between adapter 360 and body 348, thereby maintaining distal tip 340 (and the angled portion of cannula 338 immediately below distal tip 340) substantially at a position within the proximal portion of internal passageway 352. In this manner, not only cannula 338 be used for effective blood collection through connector 330, but the location of distal tip 340 within internal passage 352 of connector 330 minimizes dead space proximal to distal tip 340 within internal passage 352, thereby allowing remaining blood to be effectively washed from connector 330 after blood collection.

[0101] Although not shown or described in detail, it is understood that cannula 338, similar to cannula 138 described above, may be configured with an inner diameter and length optimized to reduce shear forces and therefore reduce hemolysis during blood collection.

[0102] 6A and 6B, in some embodiments, blood collection adapter 300 may be configured to couple to a luer lock access device 400 to receive a blood collection device, such as, for example, a BD VACUTAINER® blood collection tube. Luer lock access device 400 includes a luer lock hub 412 having internal threads that can engage with a proximal coupling portion 361 of adapter hub 360 to releasably secure blood collection adapter 300 to the luer lock access device.

[0103] The luer lock access device 400 may further include a needle 414 in fluid communication with the luer lock hub 412 to pass fluid from the blood collection adapter 300 to the blood collection device. The needle 414 may be substantially encased by a cover to protect against needlestick injury. The cover 416 may be formed of rubber or any other suitable material. The luer lock access device 400 may further include a holder 420 that is sized and configured to receive a blood collection device, such as, for example, a BD VACUTAINER® blood collection tube. In response to the blood collection device pushing the cover 416 distally toward the body luer lock hub 412, the needle 414 pierces the cover and the sharp proximal tip of the needle 414 may be inserted into the blood collection device to receive a blood sample via the blood collection adapter 300.

[0104] With reference to Figures 7A-7C, it is understood that according to embodiments of the present disclosure, a luer lock access device may have a variety of configurations. For example, as shown in Figure 7A (as well as Figures 6A and 6B), a luer lock access device 400 includes a luer lock hub 412, a needle 414, a cover 416, and a holder 420. However, as shown in Figure 7B, a luer lock access device 440 may be used according to another embodiment in which the holder is omitted, but an additional protective cover 426 is used around the needle 414 and cover 416. The protective cover 426 may be selectively removable by a user to couple a blood collection device to the needle 414. Furthermore, with reference to Figure 7C, a luer lock access device 450 may be provided that includes only the luer lock hub 412, the needle 414, and the cover 416.

[0105] 8A-8C, blood collection adapter 500 is shown in accordance with another embodiment of the present disclosure. As shown in FIG. 8A, blood collection adapter 500 includes many similar features as shown in blood collection adapter 300 and described above with respect to FIG. 5A and 5B. As such, the purpose and operation of similar components between blood collection adapter 300 and blood collection adapter 500 will not be repeated herein.

[0106] However, unlike blood collection adapter 300, which uses a cannula 338 with an angled opening proximal to tip 340, blood collection adapter 500 includes a cannula 538 with a side hole 542 located proximal to tip 540. As shown in Figures 8A and 8C, side hole 542 places cannula 538 in fluid communication with a proximal portion of internal passageway 352 of connector 330. Its location relative to internal passageway 352 is particularly useful during cleaning, since side hole 542 allows blood to be drawn through cannula 538, while fluid ejection from side hole 542 creates turbulence within connector 330 to enhance cleaning in the "dead space" of connector 330, thereby cleaning residual blood remaining in connector 330 after blood collection.

[0107] 9A-9F, a catheter system 100 and a catheter adapter 102 are shown with a blood collection adapter 300 in accordance with an embodiment of the present disclosure. Referring first to FIG. 9A, the catheter adapter 102 may be fluidly coupled to the Y-adapter 114 and may include a connector 330 (and septum) coupled thereto. As shown in FIG. 9B and described above with respect to FIG. 5A and 5B, the blood collection adapter 300 may be coupled to the connector 330 such that a cannula in the blood collection adapter 300 pierces the septum of the connector 330, placing the blood collection adapter 300 in fluid communication with the Y-adapter 114 and, therefore, the catheter adapter 102.

[0108] 9C, the luer lock access device 400 may be coupled to the blood collection adapter 300, and a blood collection container 475 may be used in combination with the luer lock access device 400 to draw blood through the catheter adapter 102. As noted above, the blood collection container 475 may be, for example, a BD VACUTAINER® blood collection tube. After completion of blood collection, the pinch clamp 128 may be closed to block the fluid path through the extension tube 122, and the blood collection container 475 and the luer lock access device 400 may be disconnected from the blood collection adapter 300. It is understood that in other embodiments of the present disclosure, the blood collection adapter and the luer lock access device 400 may be provided pre-attached via the connector 330 and other features of the catheter system 100.

[0109] After blood collection and removal of the Luer lock access device 400, a syringe 485 may be coupled to the blood collection adapter 300, as shown in FIG. 9D. As discussed above, the syringe 485 may contain a flushing fluid, such as, for example, saline. When the plunger of the syringe 485 is depressed, the flushing fluid contained therein may act to flush any remaining blood present within the connector 330.

[0110] 9E and 9F, upon completion of the flushing process, the syringe 485 may be removed from the blood collection adapter 300, and the blood collection adapter 300 may be disconnected from the connector 330. As shown in FIG. 9F and discussed in detail above with respect to FIG. 5A and 5B, the tip of the cannula of the blood collection adapter 300 is substantially protected by the side member 351 of the blood collection adapter 300 upon removal of the lever arm 346 and / or connector 330, thereby helping to prevent needle stick injury. After flushing of any remaining blood, the blood collection adapter 300 is removed and the pinch clamp 128 is opened, and the catheter system 100 may be used for an injection, another blood draw, or the like.

[0111] 10A and 10B, in some embodiments, blood collection adapter 300 may require telescopic actuation prior to blood collection. That is, as shown in FIG. 10A, inner body portion 355 with cannula 338 may be initially positioned proximal (or substantially external) to body 348 of blood collection adapter 300 such that tip 340 of cannula 338 is entirely within body 348 and does not pierce septum 331. Thereafter, when blood collection through blood collection adapter 300 is desired, inner body portion 355 and / or body 348 may be actuated relative to each other such that tip 340 of cannula 338 pierces septum 331 and provides fluid communication between blood collection adapter 300 and connector 330, as shown in FIG. 10B. In this manner, blood collection into luer lock access device 400 may be prevented until distal actuation of inner body portion 355 relative to body 348.

[0112] 5A-10B, in the embodiments described above, blood collection adapters 300, 500 are configured with a cannula having a sharp tip to pierce, for example, septum 331 of connector 330. However, in alternative embodiments, the connector may be configured as a needleless connector that does not require the septum to be pierced by a sharp tip cannula to provide fluid communication between the blood collection adapter and the catheter adapter. With reference to FIGS. 11A and 11B, a blood collection adapter 600 is shown in accordance with another embodiment of the present disclosure. Blood collection adapter 600 is configured to be used with a needleless, and thus a sharp tip cannula, thereby avoiding the possibility of needlestick injury to the blood collection adapter itself.

[0113] Blood collection adapter 600 includes a central portion 630 extending from a distal end thereof and a tip 640 extending distally from central portion 630. Tip 640 may be a substantially blunt tip that may be used with a needleless connector, as will be described in further detail herein. Tip 640 includes at least one side hole 642. As will be described in further detail below, at least one side hole 642 may not only accommodate blood draw through blood collection adapter 600, but also enhance cleaning of the needleless connector after blood draw.

[0114] 11A and 11B, blood collection adapter 600 includes a holder portion 648 having at least one gripping portion 649 with an internally threaded portion 652 that at least partially surrounds central portion 630. Internally threaded portion 652 is configured to engage with external threads of, for example, a needleless connector. Blood collection adapter 600 also includes an adapter hub 660 having a cannula 638 extending therethrough. Adapter hub 660 may include a proximal coupling portion 661 configured to secure adapter hub 660 to, for example, a Luer lock access device. While shown as a separate component in FIGS. 11A and 11B, in some embodiments, adapter hub 660 may be formed integrally with blood collection adapter 600.

[0115] 12A-12C, in some embodiments, the blood collection adapter 600 may be configured to couple to a luer lock access device 700 to receive a blood collection device, such as, for example, a BD VACUTAINER® blood collection tube. Similar to the luer lock access device 400 described above, the luer lock access device 700 includes a luer lock hub having internal threads that can engage a proximal coupling portion 661 of an adapter hub 660 to removably secure the blood collection adapter 600 to the luer lock access device. The luer lock access device 700 further includes a needle 714 in fluid communication with the luer lock hub such that fluid can pass from the blood collection adapter 600 to the blood collection device. In some embodiments, the needle 714 may be substantially encased in a shroud to protect against needlestick injury. Additionally, in some embodiments, the luer lock access device 700 may include a holder 742 that is sized and configured to receive a blood collection device, such as, for example, a BD VACUTAINER® blood collection tube. However, it is understood that other configurations of luer lock access devices may be used, similar to that described above with respect to Figures 7A-7C.

[0116] 12B and 12C show that the distal end of blood collection adapter 600 may be coupled to a needleless connector 630, with tip 640 and at least a portion of central portion 630 of blood collection adapter 600 configured to pass through a septum 634 of needleless connector 630. In some embodiments, septum 634 may be configured with a slit or another feature to allow blunt tip 640 and / or central portion 630 to pass therethrough.

[0117] 12C , tip 640 is shown in a fully distal position relative to connector 630, with tip 640, including at least a portion of at least one side hole 642, extending through septum 634 and in fluid communication with interior passageway 632 of connector 630. However, tip 640 is substantially limited in distance within interior passageway 632 through which it may travel by the interface between adapter hub 660 and body 648, thereby substantially maintaining tip 640 and at least one side hole 642 in a position within a proximal portion of interior passageway 632. In this manner, blood collection adapter 600 may not only be used for effective blood collection through connector 630, but by minimizing dead space proximal to the tip within interior passageway 632, positioning tip 640 and at least one side hole 642 within interior passageway 632 of connector 630 may effectively flush any remaining blood from connector 630 following blood collection. In some embodiments, at least a portion of the at least one side hole 642 may overlap the septum 634 to ensure that the at least one side hole 642 is below any dead space within the interior passageway 632 .

[0118] Although not shown or described in detail, like cannula 338 described above, cannula 638 may have an optimized inner diameter and length to reduce shear forces and therefore reduce hemolysis during blood collection.

[0119] 13, a portion of a luer lock access device 700 is shown in accordance with an embodiment of the present disclosure. Unlike the blood collection adapter 600 described above, which uses at least one side hole 642 to flush residual blood from the internal passageway of the needleless connector 630, the blood collection adapter 700 includes a body 748 having an extended flushing tip 738 extending distally therefrom. The extended flushing tip 738 may be sized and configured to extend through the septum 634 and at least partially into the luer tip 636 of the needleless connector 630. In this manner, the extended flushing tip 738 extends beyond the internal passageway 632, thereby bypassing the typical dead space found between the top of the septum and the cannula tip. Thus, blood drawn through the flushing tip 738 cannot reach the internal passageway 632, eliminating the need to flush the internal passageway 632 and flush residual blood from the dead space after blood collection.

[0120] 14A-14G, a catheter system 100, catheter adapter 102, and blood collection adapter 600 are shown in accordance with an embodiment of the present disclosure. Referring first to FIG. 14A, the catheter adapter 102 is fluidly coupled to a Y-adapter 114 having a needleless connector 630 (and septum) coupled thereto. As shown in FIG. 14B and 14C and described above with respect to FIG. 12A-12C, the blood collection adapter 600 may be coupled to the connector 630 such that the tip 640 and at least one side hole 642 in the blood collection adapter 600 extend through the septum of the connector 630, placing the blood collection adapter 600 in fluid communication with the Y-adapter 114, and thus with the catheter adapter 102. A blood collection adapter 700 with a holder 742 may be coupled to the blood collection adapter 600.

[0121] 14D, a blood collection container 745 may be used in combination with the luer lock access device 700 to draw blood through the catheter adapter 102. As noted above, the blood collection container 745 may be, for example, a BD VACUTAINER® blood collection tube. After completion of blood collection, the pinch clamp 128 may be closed to block the fluid path through the extension tube 122, and the blood collection container 745 and the luer lock access device 700 may be disconnected from the blood collection adapter 600. In another embodiment of the present disclosure, the blood collection adapter and the luer lock access device 700 may be provided pre-attached via the connector 630 and another feature of the catheter system 100.

[0122] After blood collection and removal of the Luer lock access device 700, a syringe 755 may be coupled to the blood collection adapter 600, as shown in FIG. 14E. As discussed above, the syringe 755 may contain a flushing fluid, such as, for example, saline. When the plunger of the syringe 755 is depressed, the flushing fluid contained therein may act to flush any remaining blood present within the connector 630.

[0123] 14F and 14G, upon completion of the flushing process, the syringe 755 may be removed from the blood collection adapter 600 and the blood collection adapter 600 may be disconnected from the connector 330. As shown in FIG. 14G and discussed in detail above with respect to FIGs. 11A and 11B, the tip 640 of the blood collection adapter 600 is blunt, thereby helping to prevent needle stick injuries commonly associated with needle connectors. After flushing of any remaining blood, the blood collection adapter 600 may be removed and the pinch clamp 128 may be opened and the catheter system 100 may be used for an injection, another blood draw, or the like.

[0124] 15A and 15B, in some embodiments, blood collection adapter 600 may require telescoping prior to blood collection, as shown in FIG. 15A, inner body portion 662 including cannula 638 and having tip 640 disposed distally thereon may initially be at least partially outside body 648 of blood collection adapter 600 such that tip 640 is entirely within body 348 and does not extend through septum 634 of connector 630. Thereafter, when blood collection through blood collection adapter 600 is desired, inner body portion 662 and / or body 648 may be actuated relative to each other such that tip 640 (and at least one side hole 642, as discussed above with respect to FIG. 11A and 11B) extends substantially through septum 634 to provide fluid communication between blood collection adapter 600 and connector 630, as shown in FIG. 15B. In this manner, blood collection into the luer lock access device 700 can be prevented until distal actuation of the inner body portion 662 relative to the body 648 .

[0125] All examples and conditional statements described herein are intended for educational purposes to help the reader understand the concepts contributed by the inventor to promote the present invention and technology, and are not to be construed as being limited to such specifically described 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 catheter system comprising: a catheter adapter having 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 a distal end of the catheter adapter; a connector coupled to the catheter adapter and including a septum; a blood collection adapter coupled to the connector, the blood collection adapter configured to create a fluid pathway through the connector; and a blood collection set coupled to the blood collection adapter, the blood collection set including a needle assembly configured to receive a blood collection container; A catheter system comprising:

2. a side port disposed between a distal end of the catheter adapter and a proximal end of the catheter adapter; an extension tube having a distal end integral with the side port of the catheter adapter and a proximal end integral with the distal end of the adapter; and an adapter having a distal end and a port; and wherein the connector is coupled to the port of the adapter. The catheter system of claim 1 .

3. The catheter system of claim 2 , wherein the adapter comprises a Y-adapter.

4. 10. The catheter system of claim 1, wherein the blood collection adapter comprises a distal portion and a proximal portion distally movable toward the distal portion, the proximal portion configured to activate a septum and create a fluid pathway through the connector in response to the proximal portion moving distally toward the distal portion.

5. The catheter system of claim 4 , wherein the proximal portion of the blood collection adapter comprises a cannula configured to be inserted into a septum of the connector to create a fluid pathway through the connector.

6. The catheter system of claim 5 , wherein the needle assembly comprises a body, a sharpened needle extending proximally from the body, and a shroud covering a proximal tip of the sharpened needle.

7. The catheter system of claim 6 , wherein the sharp needle and the cannula are formed separately and have different dimensions.

8. 7. The catheter system of claim 6, wherein the sharp needle and the cannula are formed separately and have the same dimensions.

9. 7. The catheter system of claim 6, wherein the sharp needle and the cannula are integrally formed as a single unit.

10. 10. The catheter system of claim 9, wherein the blood collection adapter and the body of the needle assembly are integrally formed as a single unit.

11. The catheter system of claim 4 , wherein the proximal portion of the blood collection adapter comprises a male luer and the connector comprises a needleless connector.

12. The catheter system of claim 11 , wherein the distal end of the cannula comprises a chamfer or a flow diverter.

13. 10. The catheter system of claim 1, wherein the blood collection adapter and the body of the needle assembly are integrally formed as a single unit.

14. 10. The catheter system of claim 1, further comprising an extension set, the extension set having a distal end coupled to the proximal end of the catheter adapter and a proximal end coupled to the connector.

15. A blood collection assembly for connection to the catheter assembly, comprising: The blood collection assembly includes: a needle assembly including a body, a sharpened needle extending proximally from the body, and a cover covering a proximal tip of the sharpened needle; a blood collection adapter coupled to a distal end of the needle assembly; the blood collection adapter configured to create a fluid pathway through the connector. Blood collection assembly.

16. 16. The blood collection assembly of claim 15, wherein the blood collection adapter is directly and movably coupled to the needle assembly.

17. 16. The blood collection assembly of claim 15, wherein the blood collection adapter is integrally formed as a single unit with the body of the needle assembly.

18. 16. The blood collection assembly of claim 15, wherein the blood collection adapter comprises a distal portion and a proximal portion movable distally toward the distal portion, the proximal portion of the blood collection adapter comprising a male luer or cannula configured to activate a septum of the connector and create a fluid pathway through the connector in response to moving the proximal portion distally toward the distal portion.

19. Connecting a blood collection assembly to a catheter assembly, comprising: The catheter assembly includes: a catheter adapter having 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 from a distal end of the catheter adapter; and a connector coupled to the catheter adapter and comprising a septum; the blood collection assembly includes a needle assembly and a blood collection adapter, the blood collection adapter including a distal portion and a proximal portion movable distally toward the distal portion, the proximal portion of the blood collection adapter including a male luer or cannula; moving the proximal portion distally towards the distal portion, the male luer or cannula configured to activate a septum of the connector and create a fluid pathway through the connector in response to moving the proximal portion distally towards the distal portion; collecting blood in a blood collection device coupled to the needle assembly after moving the proximal portion distally toward the distal portion.

20. The catheter adapter further comprises: a side port disposed between a distal end of the catheter adapter and a proximal end of the catheter adapter; an extension tube having a distal end integral with the side port of the catheter adapter and a proximal end integral with the distal end of the adapter; and an adapter having a distal end and a port; 20. The method of claim 19, further comprising: wherein the connector is coupled to a port of the adapter.

21. 20. The method of claim 19, further comprising the step of flushing the catheter assembly or injecting fluid through the catheter assembly after disconnecting the blood collection set and removing the needle assembly from the blood collection set.

22. 1. A catheter system comprising: a catheter adapter having 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 a distal end of the catheter adapter; a connector coupled to the catheter adapter and including a septum; and a blood collection adapter coupled to the connector; A catheter system, wherein the blood collection adapter comprises a cannula configured to be inserted into a septum of the connector to create a fluid pathway through the connector.

23. The blood collection adapter includes a body and at least two opposing lever arms coupled to the body via respective flex points; 23. The catheter system of claim 22, further comprising at least two opposing lever arms configured to releasably couple a blood collection adapter to the connector.

24. 24. The catheter system of claim 23, wherein the blood collection adapter further comprises an adapter hub coupled to the body, the adapter hub comprising an inner body portion that surrounds a portion of the cannula.

25. 25. The catheter system of claim 24, wherein the adapter hub further comprises a proximal connection portion configured to connect the blood collection adapter to a Luer lock access device.

26. 26. The catheter system of claim 25, wherein the luer lock access device further comprises a luer lock hub having internal threads capable of engaging an adapter hub, a needle, and a proximal coupling portion of a sheath surrounding the needle.

27. 27. The catheter system of claim 26, wherein the luer lock access device further comprises a holder configured to hold a blood collection device.

28. 27. The catheter system of claim 26, wherein the luer lock access device further comprises a protective cover at least partially surrounding the needle and the shroud.

29. The catheter system of claim 22 , wherein the cannula comprises a beveled tip.

30. 30. The catheter system of claim 29, wherein the beveled tip of the cannula is configured to extend only into a proximal portion of the internal passage of the connector after the cannula is inserted into the septum.

31. 23. The catheter system of claim 22, wherein the cannula comprises at least one side hole.

32. 32. The catheter system of claim 31, wherein the at least one side hole of the cannula is configured to extend only into a proximal portion of the internal passage of the connector after the cannula is inserted into the septum.

33. 1. A catheter system comprising: a catheter adapter having 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 a distal end of the catheter adapter; a needleless connector coupled to the catheter adapter and including a septum; and a blood collection adapter coupled to the needleless connector; A catheter system in which the blood collection adapters have blunt tips extending from their distal ends and include a central portion configured to be inserted into a septum of the needleless connector to create a fluid pathway through the needleless connector.

34. 34. The catheter system of claim 33, wherein the blood collection adapter comprises at least one side hole disposed adjacent the blunt tip.

35. 35. The catheter system of claim 34, wherein the at least one side hole is configured to extend only into a proximal portion of the internal passage of the needleless connector after the blunt tip is inserted into the septum.

36. 34. The catheter system of claim 33, wherein the blood collection adapter further comprises an adapter hub coupled to the holder portion, the adapter hub comprising an inner body portion that surrounds a portion of the cannula.

37. 37. The catheter system of claim 36, wherein the cannula extends between the adapter hub and the blunt tip to form a fluid pathway therebetween.

38. 37. The catheter system of claim 36, wherein the adapter hub further comprises a proximal connection portion configured to connect the blood collection adapter to a Luer lock access device.

39. 40. The catheter system of claim 38, wherein the luer lock access device further comprises a luer lock hub having internal threads capable of engaging an adapter hub, a needle, and a proximal coupling portion of a sheath surrounding the needle.

40. 40. The catheter system of claim 39, wherein the luer lock access device further comprises a holder configured to hold a blood collection device.

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