Blood collection device, system, and method for facilitating air priming.

Abstract

We provide a blood collection system that prevents blood contamination. [Solution] The blood collection system comprises an adapter having a distal port, a first proximal port, and a second proximal port, and a blood collection device connected to the first proximal port, the blood collection device comprising a body having a distal end, a proximal end, and a longitudinal axis extending between them, a septum disposed within the body, a cannula having a distal end and a sharp proximal end and extending through the septum, an elastomer sleeve coupled to the body and covering the sharp proximal end of the cannula, an air pipe extending through the septum, and an air membrane disposed proximal to the air pipe, wherein the air priming pathway comprises the air pipe and the air membrane, and a separate blood collection pathway comprises the cannula.

Description

Technical Field

[0001] The present invention relates to a blood collection device, system, and method for facilitating air priming.

Background Art

[0002] This application claims the priority of U.S. Provisional Application Serial No. 63 / 081,091, filed on September 21, 2020, entitled "Blood Collection Device, System, and Method for Facilitating Air Priming."

[0003] Typically, intravenous catheters are used in various infusion therapies. For example, an intravenous catheter can be used to infuse fluids such as normal saline, various drugs, and total parenteral nutrition into a patient. An intravenous catheter can also be used to collect blood from a patient.

[0004] Common types of intravenous catheters are peripheral IV catheters ("PIVC"), peripherally inserted central catheters ("PICC"), and midline catheters. An intravenous catheter can include an "over-the-needle" catheter that can be mounted on a needle having a sharp distal tip. The sharp distal tip can be used to puncture the patient's skin and vascular system. Insertion of the intravenous catheter into the vascular system can follow puncture of the vascular system by the needle. Generally, the needle and the intravenous catheter are inserted at a shallow angle through the skin into the patient's vascular system with the bevel of the needle facing up and away from the patient's skin.

[0005] To confirm that the introducer needle and / or the intravenous catheter are properly positioned within the vascular system, generally, the user confirms that there is a flashback of blood visible to the user. In some cases, the introducer needle includes a notch disposed toward the distal end of the introducer needle, and in response to the distal tip of the introducer needle disposed within the vascular system, blood can flow proximally through the needle lumen, pass through the notch, exit the needle lumen, and then move proximally between the outer surface of the introducer needle and the inner surface of the intravenous catheter.

[0006] Therefore, if the venous catheter is at least partially transparent, the user can visualize a "flashback" of a small amount of blood, thereby confirming the placement of the venous catheter within the vascular system. The presence of a vascular inlet indicator such as a flashback can facilitate the successful placement of the venous catheter. The flashback can also be used to perform air priming to purge air from the flow path. Once the placement of the inlet needle within the vascular system is confirmed, the user can temporarily interrupt the flow in the vascular system and withdraw the inlet needle, leaving the venous catheter in place for future blood collection and / or infusion.

[0007] For blood collection, a blood collection tube may be attached to a catheter via a connector. For example, a VACUTAINER® blood collection tube may include a sterile glass or plastic test tube with a rubber stopper that creates a vacuum inside the tube to facilitate the extraction of a predetermined amount of blood from the patient. A double-ended needle may be used to collect blood from the patient. The proximal end of the needle may be positioned inside the holder, and the distal end of the needle may be inserted into the patient's catheter or vein. When the VACUTAINER® blood collection tube is inserted into the holder, the rubber stopper may be punctured by the proximal end of the needle, and the vacuum inside the tube may draw blood into the tube through the needle. The filled tube may then be removed, and another tube may be inserted and filled in the same manner.

[0008] The subject matter claimed herein is not limited to embodiments that resolve disadvantages or embodiments that operate only in the environments described above. Rather, this background is provided merely to illustrate an example of the technical field in which some of the embodiments described herein may be carried out. [Overview of the project] [Problems that the invention aims to solve]

[0009] This disclosure relates, in general, to blood collection devices, systems, and methods for priming blood pathways. In some embodiments, the blood collection device may include a cannula, a holder, and an elastomer sleeve. In some embodiments, the cannula may include a proximal end, a distal end, and a lumen extending along the longitudinal axis between them. Some embodiments of the cannula may include a slot to allow a user to visualize the blood pathway through the cannula. [Means for solving the problem]

[0010] In some embodiments, the holder may include a proximal end, a distal end, and a channel extending between them. Some embodiments of the channel may be configured to align with the longitudinal axis to hold the shaft of the cannula. In some embodiments, the holder may include a visual check window corresponding to a slot in the cannula.

[0011] In some embodiments, the elastomer sleeve may be coupled to a holder and surround the proximal end of the cannula. In some embodiments, a priming opening may be positioned between the elastomer sleeve and the holder to prime the blood flow path. In some embodiments, the priming opening may automatically seal in response to the blood collection tube being coupled to the holder. In some embodiments, the elastomer sleeve may automatically seal the priming opening.

[0012] In some embodiments, the holder may be configured to connect to a blood collection tube, with the proximal end of the cannula and the elastomer sleeve extending through the distal end of the blood collection tube. In some embodiments, the holder may be configured to connect to a needleless connector. In some embodiments, the holder may include a contact interface for physical manipulation of the cannula.

[0013] In some embodiments, the holder may include a projection extending from the proximal end of the holder along the longitudinal axis. Some embodiments of the projection may include at least a portion of a channel. In some embodiments, the projection may include a priming opening.

[0014] Some embodiments of the blood collection system may include an adapter such as a Y-shaped adapter having a distal end, a first proximal port, and a second proximal port. In some embodiments, the blood collection system may further include a blood collection device coupled to the first proximal port.

[0015] In some embodiments, the blood collection device may include a body comprising a distal end, a proximal end, and a longitudinal axis extending between them. In some embodiments, a septum may be located within the body. In some embodiments, a cannula having a distal end and a sharp proximal end may extend through the septum. In some embodiments, an elastomer sleeve may be connected to the body and cover the sharp proximal end of the cannula.

[0016] In some embodiments, an air pipe may extend through the septum. In some embodiments, an air membrane may be positioned proximal to the air pipe. Some embodiments of the air priming pathway may include an air pipe and an air membrane. In some embodiments, a blood collection pathway separate from the air priming pathway includes a cannula.

[0017] In some embodiments, the distal end of the body may include a male Luer adapter, and the cannula may extend through the proximal end of the body. In some embodiments, the body may include an extension between the septum and the elastomer sleeve. Some embodiments of the extension may be configured to be held by the user. In some embodiments, an air membrane may be located within the extension.

[0018] In some embodiments, the elastomer sleeve may automatically seal the air priming path in response to the blood collection tube being coupled to the body. In some embodiments, the blood collection system may further include a sealing ring positioned within the first proximal port so that the cannula extends through the sealing ring. In some embodiments, the sealing ring may be positioned at the distal end of the first proximal port. In some embodiments, the sealing ring may be positioned adjacent to the septum.

[0019] In some embodiments, the air pipe may include multiple channels. Some embodiments of the blood collection pathway may include a first channel, and some embodiments of the air priming pathway may include a second channel. In some embodiments, the air priming pathway may include an air rod that replaces the air pipe and air membrane. Some embodiments of the air rod may include a porous material that allows air to pass through and blocks liquid. In some embodiments, the air rod may be integrated with the body of the blood collection device.

[0020] It should be understood that both the general description above and the detailed description below are examples and illustrative, and do not limit the claimed invention. It should be understood that various embodiments are not limited to the configurations and means shown in the drawings. It should also be understood that embodiments may be combined, or other embodiments may be utilized, and that, unless claimed, structural modifications may be made without departing from the scope of the various embodiments of the invention. Therefore, the detailed description below should not be interpreted as restrictive. [Brief explanation of the drawing]

[0021] Exemplary embodiments will be described and illustrated with additional specifics and details by using the attached figures.

[0022] [Figure 1A]A top perspective view of a blood collection system implementing a Y-shaped adapter according to some embodiments. [Figure 1B] A top perspective view of another exemplary blood collection system implementing a Y-shaped adapter according to some embodiments. [Figure 2A] A side perspective view of a blood collection device used in connection with a Y-shaped adapter according to some embodiments. [Figure 2B] Another side perspective view of the blood collection device of FIG. 2A used in connection with the Y-shaped adapter of FIG. 2A according to some embodiments. [Figure 2C] A top perspective view of the blood collection device of FIG. 2A used in connection with the Y-shaped adapter of FIG. 2A according to some embodiments. [Figure 3] A perspective view of a plurality of blood collection devices according to some embodiments. [Figure 4A] A perspective view of one of the blood collection devices of FIG. 3 integrated with an exemplary catheter according to some embodiments. [Figure 4B] A perspective view of one of the blood collection devices of FIG. 3 integrated with an exemplary catheter assembly according to some embodiments. [Figure 4C] A top cross-sectional view of one of the blood collection devices of FIG. 3 integrated with an exemplary catheter adapter according to some embodiments. [Figure 5] A cross-sectional view of an exemplary blood collection device according to some embodiments. [Figure 6] A perspective view of the blood collection device of FIG. 5 according to some embodiments. [Figure 7] A cross-sectional view of another exemplary blood collection device according to some embodiments. [Figure 8] A perspective view of the blood collection device of FIG. 7 according to some embodiments. [Figure 9A] A perspective view of an exemplary holder according to some embodiments. [Figure 9B] A cross-sectional view of another exemplary catheter system according to some embodiments. [Figure 10A] This is a perspective view of another exemplary holder according to several embodiments. [Figure 10B] This is a perspective view of an exemplary blood collection device incorporating the holder shown in Figure 10A, according to several embodiments. [Figure 11A] This is a perspective view of another exemplary holder according to several embodiments. [Figure 11B] This is a perspective view of an exemplary blood collection device incorporating the holder shown in Figure 11A, according to several embodiments. [Figure 12A] This is a perspective view of another exemplary holder according to several embodiments. [Figure 12B] This is a perspective view of an exemplary blood collection device incorporating the holder shown in Figure 12A, according to several embodiments. [Figure 13A] This is a perspective view of another exemplary holder according to several embodiments. [Figure 13B] This is a perspective view of an exemplary blood collection device incorporating the holder shown in Figure 13A, according to several embodiments. [Figure 14] This is a cross-sectional perspective view of an exemplary blood collection device integrated with a Y-shaped adapter, according to several embodiments. [Figure 15] Figure 14 is a cross-sectional perspective view of an exemplary blood collection device according to several embodiments. [Figure 16A] This is a perspective view of an exemplary seal ring according to several embodiments. [Figure 16B] This is a perspective view of another exemplary seal ring according to several embodiments. [Figure 17A] Figure 16B is a cross-sectional perspective view of an exemplary blood collection device showing a sealing ring according to several embodiments. [Figure 17B] This is a cross-sectional perspective view of another exemplary blood collection device showing the sealing ring of Figure 16A, according to several embodiments. [Figure 18A] This is a cross-sectional perspective view of an exemplary blood collection device showing an air pipe with multiple channels according to several embodiments. [Figure 18B] This is an enlarged view of a portion of the blood collection device and air pipe shown in Figure 18A, according to several embodiments. [Figure 19A] This is a cross-sectional perspective view of an exemplary blood collection device, showing an exemplary air pipe according to several embodiments. [Figure 19B] This is a cross-sectional perspective view of an exemplary blood collection device, showing an exemplary air rod according to several embodiments. [Modes for carrying out the invention]

[0023] All examples and conditional language listed herein are intended for educational purposes to help the reader understand the invention and to support the concepts to which the inventors have contributed to advancing the art, and should be interpreted not as limiting, as are the examples and conditions specifically listed. While embodiments of the invention have been described in detail, it should be understood that various modifications, substitutions, and alternatives can be made without departing from the spirit and scope of the invention.

[0024] Referring here to Figures 1A and 1B, in some embodiments, the blood collection system 10 may communicate with the catheter assembly 2 via an adapter 14 such as a Y-shaped adapter. In some embodiments, the catheter 4 of the catheter assembly 2 may be placed in the patient's vascular system not only for blood collection but also for the injection of saline solution or medication.

[0025] In some embodiments, before inserting the catheter 4 into the vascular system, medical fluid or saline may be injected through the side port 6 of the adapter 14 to purge air from the flow path. However, when a vacuum blood collection tube 50 is connected to the adapter 14, the medical fluid or saline may mix with the blood sample, thereby diluting the blood sample and potentially leading to an inaccurate diagnosis. Some clinicians utilize blood flashback to purge air from the flow path. However, if the air priming procedure is not performed correctly or adequately, blood may clot within the adapter 14 after blood sampling. Embodiments disclosed herein address these and other issues.

[0026] Some embodiments of the blood collection system 10 may include an adapter 14 having a distal port 58, a first proximal port opening 60, and a second proximal port 62. In some embodiments, the adapter 14 may include a Y-adapter, a T-adapter, or other suitable adapter 14. In some embodiments, for example, the blood collection device 12 may be coupled to the first proximal port 60 via a needleless adapter 54 such as a Luer adapter.

[0027] Referring here to Figure 1A, in some embodiments, the blood collection device 12 may include a cannula 22 having a slot 32 so that the user can visualize the blood flow path through the cannula 22. In some embodiments, the shaft 42 of the cannula 22 may be held by a holder 34. In some embodiments, the cannula 22 may be made of steel or another suitable biocompatible material. In some embodiments, the holder 34 may be made of polymer, rubber, or another suitable material. Some embodiments of the holder 34 may include a visual check window 44 corresponding to the slot 32 of the cannula 22.

[0028] In some embodiments, the elastomer sleeve 46 may be coupled to the holder 34 and surround the proximal end 24 of the cannula 22. In some embodiments, a priming opening 48 may be positioned between the elastomer sleeve 46 and the holder 34 to prime the blood flow path. In some embodiments, the priming opening 48 may automatically seal in response to the blood collection tube 50 being coupled to the holder 34.

[0029] Referring here to Figure 1B, in some embodiments, the blood collection device 12 may include a body 64 having a septum 72 positioned therein. In some embodiments, a cannula 22 having a distal end 76 and a sharp proximal end 78 may extend through the septum 72. In some embodiments, an elastomer sleeve 46 may be coupled to the body 64 to cover the sharp proximal end 78 of the cannula. In some embodiments, an air priming path may be separated from the blood collection path to prime the blood collection device 12. In some embodiments, the elastomer sleeve 46 may automatically seal the air priming path in response to the blood collection tube 50 being coupled to the body 64.

[0030] Referring here to Figures 2A, 2B, and 2C, some prior art blood sampling devices 12 carry the risk of contamination by residual blood 98 in the adapter 14 and / or needleless adapter 54 after blood sampling. Indeed, if the air priming procedure is not performed correctly or adequately, residual blood 98 may contaminate the injector or blood sample obtained after the air priming procedure.

[0031] As shown in Figures 2A and 2B, in the prior art blood collection device 12, residual blood 98 commonly accumulates along the inner wall of the adapter 14, typically at or near the junction between the first proximal port 60 and the second proximal port 62, or at the distal port 58. It is also common for residual blood 98 to accumulate along or within the threads or slits of the needleless adapter 54, or along the surface of the cap 100 attached to the needleless adapter 54. In some cases, as shown in Figure 2C, blood 98 may coagulate in the adapter 14 and / or in the catheter or tube attached thereto. This can clog the fluid pathway, in addition to contaminating the injectable fluid or blood sample obtained after the air priming procedure.

[0032] In other cases, a prior art blood collection device 12 may not allow the user to visualize a blood flashback without the blood collection tube 50 attached thereto. In other cases, some prior art blood collection devices 12 may not consider at all the implementation of an air priming procedure that could adversely affect the volume of the first sample.

[0033] Referring here to Figure 3, several embodiments of the blood collection device 12 disclosed and claimed herein may address the risks and drawbacks of the prior art devices described above. As shown in Figure 3, in some embodiments the blood collection device 12 may include a cannula 22, a holder 34, and an elastomer sleeve 46. In some embodiments the cannula 22 may include a proximal end 24, a distal end 26, and a lumen 20 between them. In some embodiments the lumen 20 may extend along a longitudinal axis 30.

[0034] Some embodiments of the holder 34 may allow a user to hold and physically manipulate the cannula 22. In some embodiments, the holder 34 may include a contact interface 56 for physical manipulation of the cannula 22. In some embodiments, the holder 34 may include a proximal end 36, a distal end 38, and a channel 40 extending between them. Some embodiments of the channel 40 may hold the shaft 42 of the cannula 22.

[0035] Some embodiments of the cannula 52 may include a slot 32 that allows the user to visualize the blood flow path through the cannula 22. Similarly, some embodiments of the holder 34 may include a visual check window 44 corresponding to the slot 32 of the cannula 22. Some embodiments of the blood collection device 12 may be configured such that the slot 32 aligns with a visual check window 454, so that the user can visualize the blood flow path or blood flashback through the blood collection device 12.

[0036] In some embodiments, the elastomer sleeve 46 may be connected to the holder 34 and surround the proximal end 24 of the cannula 22. Some embodiments of the elastomer sleeve 46 may include rubber or another suitable elastomer material. In some embodiments, the elastomer sleeve 46 may be biocompatible and substantially impermeable to liquids.

[0037] In some embodiments, one or more priming openings 48 may be located between the elastomer sleeve 46 and the holder 34, with an interface in close proximity between them. In some embodiments, the elastomer sleeve 46 may function as a trigger for priming and blood sampling. For example, when the blood collection device 12 is inserted into the patient's vascular system, the elastomer sleeve 46 may prime the air present in the blood flow path through the priming opening 48. Some embodiments of the priming opening 48 may include a clearance opening 54 and a priming slot 55. In some embodiments, the blood present in the blood flow path may be retained by the elastomer sleeve 46 rather than leaking out through the priming opening 48 due to the high surface tension and viscosity of the blood.

[0038] In some embodiments, connecting the blood collection tube 50 to the holder 34 may compress the elastomer sleeve 46 to tightly seal the elastomer sleeve 46 at the priming opening 48. In some embodiments, the blood collection device 12 may then automatically begin collecting the blood sample. The blood collection device 12 may automatically stop collecting the blood sample when the blood collection tube 50 is removed from the holder 34. Similarly, some embodiments of the blood collection device 12 may automatically perform an air priming procedure before sample collection, and the air priming procedure may automatically stop when the blood collection tube 50 is attached to the blood collection device 12.

[0039] Referring here to Figures 4A-4C, in some embodiments, the holder 34 may be configured to connect to the blood collection tube 50 so that the sharp proximal end 78 of the cannula 22 and the elastomer sleeve 46 can extend through the distal end of the blood collection tube 50. Some embodiments of the blood collection device 12 may be used independently or in connection with an existing catheter system or blood collection set 102. As shown in Figure 4A, some embodiments of the blood collection device 12 may be attached to a blood collection system 10, for example, a peripheral IV catheter ("PIVC"). As shown in Figure 4B, some embodiments of the holder 34 may be configured to connect to a needleless adapter 54. As shown in Figure 4C, some embodiments of the holder 34 may be configured to connect to the proximal end of a catheter adapter 104.

[0040] Referring to Figures 5 and 6, in some embodiments, the holder 34 may include a projection 52 extending from the proximal end 36 of the holder 34 along the longitudinal axis 30. Some embodiments of the projection 52 may include at least a portion of the channel 40. In some embodiments, the shaft 42 of the cannula 22 may be held by the channel 40 such that the projection 52 supports the proximal end 24 of the cannula 22 as it extends into the elastomer sleeve 46.

[0041] In some embodiments, the projection 52 may include one or more priming openings 48. For example, as shown in the enlarged view of Figure 5, a clearance opening 53 may extend through the projection 52 along the longitudinal axis 30. Thus, some embodiments of the projection 52 may provide a clearance space between the outer surface of the cannula 22 and the inner surface of the projection 52, thereby allowing the cannula 22 to be manipulated relative to the projection 52.

[0042] As shown in Figure 6, some embodiments of the cannula 22 may include a slot 32 to provide an unobstructed visualization of a small amount of blood passing through the cannula 22. In some embodiments, visualization such as a blood flashback may provide confirmation of a vein.

[0043] Some embodiments of the holder 34 may include a visual check window 44 configured to align with the slot 32 when the holder 34 holds the shaft 42 of the cannula 22. Some embodiments of the visual check window 44 may include an opening or slot located in the holder 34 and positioned to correspond to the slot 32 of the cannula 22. In some embodiments, the visual check window 44 may include an opening having at least the same size and shape as the slot 32 for visualizing a blood flashback through it. In some embodiments, the visual check window 44 may include stepped dimensions that increase from the inner surface of the holder 34 adjacent to the slot 32 toward the outer surface of the holder 34. Some embodiments of the visual check window 44 may include a circular, rectangular, polygonal, or any other suitable shape and / or cross-sectional shape.

[0044] Referring now to Figures 7 and 8, in some embodiments, the projection 52 may include one or more priming openings 48 between the proximal end 36 of the holder 34 and the projection 52. In some embodiments, the priming openings 48 may include a priming slot 55 positioned along the proximal end 36 of the holder 34 laterally with respect to the longitudinal axis 30. In some embodiments, the priming openings 48 may further include a clearance opening 53 integrated through the holder 34 and the projection 52 between the channel 40 and the cannula 22 along the longitudinal axis 30.

[0045] In some embodiments of the priming slot 55, when an external force is applied, such as the force applied by the blood collection tube 50 attached to the proximal end of the holder 34, it may be selectively blocked by the elastomer sleeve 46. In some embodiments, the elastomer sleeve 46 may deform to passively block the priming slot 55 or other priming openings 48. In some embodiments, the deformation of the elastomer sleeve 46 may cause the proximal end 24 of the cannula 22 to extend through the proximal end of the elastomer sleeve 46.

[0046] Figures 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, and 13A, 13B show various embodiments of the priming opening 48 integrated with various embodiments of the holder 34 and the projection 52. As shown in Figures 9A and 9B, for example, some embodiments of the priming opening 48 may include one or more priming slots 55 integrated with the outer surface of the proximal end 36 of the holder 34. Some embodiments may include a single priming slot 55 positioned laterally with respect to the longitudinal axis 30, as shown in Figure 9A. Some embodiments may include two priming slots 55 positioned in opposite directions with respect to the longitudinal axis 30, as shown in Figure 9B. In some embodiments, the projection 52 may be coupled to or integrated with the proximal end 36 of the holder 34 so that the projection 52 can be superimposed on one or more priming slots 55. In some embodiments, the channel 40 may extend through the center of the projection 52 and the holder 34 to hold the cannula 22 therein.

[0047] As shown in Figures 10A and 10B, some embodiments of the projection 52 may include a priming opening 48 integrated into its side wall such that the channel 40 is open on at least one side. In some embodiments, the priming opening 48 may be further integrated into at least a portion of the proximal end 36 of the holder 34.

[0048] As shown in Figures 11A and 11B, some embodiments of the holder 34 may include an elongated portion 108 having a projection 52 extending therefrom along the longitudinal axis 30. In some embodiments, the elongated portion 108 may include one or more threads 106 or other suitable engagement mechanisms. Some embodiments of the elongated portion 108 may include a priming opening 48. As shown, the priming opening 48 may include a single priming hole 110 integrated into the elongated portion 108 near the contact point between the proximal end of the elongated portion 108 and the distal end of the elastomer sleeve 46. In other embodiments, as shown in Figures 12A and 12B, the elongated portion 108 may include a plurality of priming holes 110 integrated into its surface and / or threads 106.

[0049] Referring now to Figures 13A and 13B, in some embodiments the priming opening 48 may include a priming slot 55 integrated with the projection 52 and extending into at least a portion of the elongated portion 108 and / or the thread 106. In any case, the priming slot 55 may be blocked and / or sealed by the elastomer sleeve 46 when an external force is applied to deform the elastomer sleeve 46.

[0050] Referring here to Figures 14 and 15, some embodiments of the blood collection device 12 may include a body 64 having a distal end 66, a proximal end 68, and a longitudinal axis 70 extending between them. In some embodiments, the outer surface of the body 64 may provide a contact interface 56 for user recognition. Some embodiments of the contact interface 56 may include ridges, bumps, mesh, or other suitable textures or structures to provide firm recognition. In some embodiments, a septum 72 may be located within the body 64.

[0051] In some embodiments, the cannula 22, having a distal end 76 and a sharp proximal end 78, may extend through the septum 72. In some embodiments, the cannula 22 may be made of steel or may contain any other suitable material. In some embodiments, an elastomer sleeve 46 may be coupled to the body 64 to cover the sharp proximal end 78 of the cannula 22. Some embodiments of the elastomer sleeve 46 may be fluid-impermeable and biocompatible. For example, in some embodiments, the elastomer sleeve 46 may contain rubber or another suitable material. In some embodiments, the elastomer sleeve 46 may automatically seal the air priming path in response to the blood collection tube 50 being coupled to the body 64.

[0052] In some embodiments, the blood collection device 12 may be coupled to a port of an adapter 14. As shown in Figure 14, for example, some embodiments of the adapter 14 may include a first proximal port 60, a second proximal port 62, and a distal port 58. In some embodiments, the blood collection device 12 may be coupled to the first proximal port 60 via a needleless adapter 54, such as a Luer adapter. For example, as shown, some embodiments of the blood collection device 12 may include a male Luer adapter 84 configured to connect to the first proximal port 60. In some embodiments, the distal end 66 of the body 64 of the blood collection device 12 may include a male Luer adapter 84, and the cannula 22 may extend through the proximal end 68 of the body 64. In some embodiments, the proximal end 68 of the body 64 may be configured to connect to a blood collection tube 50, such as a VACUTAINER®. In some embodiments, the sharp proximal end 78 of the cannula 22 may extend into the blood collection tube 50 to provide a route for blood sampling.

[0053] In some embodiments, the air priming path of the blood collection device 12 may be separated from the blood collection path to prevent blood from contaminating the first proximal port 60. In some embodiments, for example, as shown in Figures 16A and 16B, a seal ring 88 may be located within the first proximal port 60, and the cannula 22 may extend through it. As shown in Figure 16A, some embodiments of the seal ring 88 may be located adjacent to the septum 72. As shown in Figure 16B, other embodiments of the seal ring 88 may be located at the distal end 66 of the first proximal port 60. In some embodiments, the seal ring 88 may also isolate blood within the cannula 22 to prevent blood from contaminating the internal cavity of the adapter 14.

[0054] In some embodiments, the body 64 may include at least some air priming paths to prime air to the outside of the adapter 14. For example, some embodiments of the body 64 may include an air pipe 80 and an air membrane 82. In some embodiments, the air pipe 80 may extend through the septum 72. In some embodiments, the air pipe 80 may penetrate the septum 72. In some embodiments of the septum 72, it may self-seal when the air pipe 80 and / or cannula 22 are withdrawn. In some embodiments, the body 64 and septum 72 of the blood collection device 12 may be used as a needleless adapter 54 when the air pipe 80 and cannula 22 are withdrawn from them.

[0055] In some embodiments of the air membrane 82, it may be located proximal to the air pipe 80. In some embodiments, the body 64 may include an extension 86 between the septum 72 and the elastomer sleeve 46, configured to be held by the user. In some embodiments of the air membrane 82, it may be located within the extension 86. In some embodiments, the air priming path, including the air pipe 80 and the air membrane 82, may automatically seal in response to the blood collection tube 50 being coupled to the body 64.

[0056] Referring here to Figures 17A and 17B, in some embodiments, at least a portion of the blood collection device 12 may be disposable, while the remaining components of the blood collection device 12 may be reusable, thereby streamlining the procedure and facilitating future blood sampling procedures. As shown in Figures 17A and 17B, in some embodiments, the cannula 22, body 64, air pipe 80 and air membrane 82, and elastomer sleeve 46 may be discarded for injection or placement, for example, while the seal ring 88, male Luer adapter 84 and septum 72 remain coupled to the first proximal port 60 of the adapter 14 and can be reused. As previously stated, the seal ring 88 may be seated on the distal end 66 or proximal end 68 of the body 64, depending on its purpose and / or manufacturing process.

[0057] Referring here to Figures 18A and 18B, in some embodiments the air pipe 80 may include a plurality of channels 90. In some embodiments, some of the channels 90 may be used for blood sampling and other channels 90 may be used for air priming. For example, as shown in Figure 18B, in some embodiments the first channel 92 may be used for blood collection and the second channel 94 may be used for air priming. In some embodiments the second channel 94 may be sealed at both ends and may include one or more openings to provide air priming.

[0058] Referring here to Figures 19A and 19B, some embodiments of the air priming path may include a porous air rod 96 instead of the air pipe 80 and air membrane 82. Some embodiments of the air rod 96 may include a porous material that is air-permeable and liquid-impermeable. Thus, some embodiments of the air rod 96 may be configured to allow free flow of air through it while preventing liquid from penetrating the air rod 96.

[0059] In some embodiments, the air rod 96 may be integrated with the body 64 of the blood collection device 12. In other embodiments, the air rod 96 may be detached from the body 64 and / or septum 72 of the blood collection device 12 after the blood sampling procedure has been performed.

[0060] All examples and conditional language listed herein are intended for educational purposes to help the reader understand the invention and to support the concepts to which the inventors have contributed to advance the technology, and should be construed as not being limited to such specifically listed examples and conditions. While embodiments of the invention have been described in detail, it should be understood that various modifications, substitutions, and alternatives are possible without departing from the spirit and scope of the invention.

Claims

1. It is a blood collection system, An adapter comprising a distal port, a first proximal port, and a second proximal port, A blood collection device connected to the first proximal port, A body comprising a distal end, a proximal end, and a longitudinal axis extending between them, The septum located inside the main body, A cannula having a distal end and a sharp proximal end, extending through the septum, An elastomer sleeve, which is connected to the main body and covers the sharp proximal end of the cannula, An air pipe extending through the septum, A blood collection device comprising an air membrane positioned near the air pipe, A blood collection system comprising an air priming pathway comprising the air pipe and the air membrane, and a separate blood collection pathway comprising the cannula.

2. The blood collection system according to claim 1, wherein the distal end of the main body is equipped with a male Luer adapter, and the cannula extends through the proximal end of the main body.

3. The blood collection system according to claim 1, wherein the main body comprises an extendable portion configured to be held by the user between the septum and the elastomer sleeve, and the air membrane is disposed within the extendable portion.

4. The blood collection system according to claim 1, wherein the elastomer sleeve automatically seals the air priming path in response to the blood collection tube being connected to the main body.

5. The blood collection system according to claim 1, further comprising a sealing ring positioned within the first proximal port such that the cannula extends through it.

6. The blood collection system according to claim 5, wherein the sealing ring is positioned at the distal end of the first proximal port.

7. The blood collection system according to claim 5, wherein the sealing ring is positioned adjacent to the septum.

8. The blood collection system according to claim 1, wherein the air pipe comprises a plurality of channels.

9. The blood collection system according to claim 1, wherein the blood collection route includes a first channel of the plurality of channels, and the air priming route includes a second channel of the plurality of channels.

10. The blood collection system according to claim 1, wherein the air priming path comprises an air rod for replacing the air pipe and the air membrane, and the air rod comprises a porous material that allows air to pass through and blocks liquid.

11. The blood collection system according to claim 10, wherein the air rod is integrated with the main body.

Images